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NCT Number: NCT07785934

Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity

This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.

The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.

The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.

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Key information

Conditions

Drug Drug Interaction (DDI) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pharmacokinetics and Pharmacodynamics Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230061, China

Location status: Recruiting

Location contact

Wei Hu, PhD

CONTACT

[email protected]

+86-13856086475

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 includes male participants only, and Cohort 2 includes both male and female participants.
  • Body weight ≥50.0 kg, body mass index (BMI) ranging from 24.0 to 35.0 kg/m² inclusive (BMI = weight(kg)/height²(m²)).
  • Participants (including their partners) have no plan to conceive from screening through 6 months after study completion, are willing to adopt contraceptive measures specified in the study, and have no plan to donate sperm or ova within 6 months after trial completion.
  • Participants are able to communicate well with investigators, have fully understood this study, voluntarily participate in it, understand and comply with all study requirements, and provide written informed consent.

Exclusion criteria

  • Known hypersensitivity or intolerance to investigational product or its excipients, or hypersensitivity to other GLP-1, GIP, GCG receptor agonists; or prior history of multiple or severe clinically significant drug hypersensitivity reactions; or active allergic disease or high-sensitivity constitution;
  • History or evidence of any of the following diseases:
  • Personal or family history (first-degree relatives: parents, children or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
  • History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal-cell or squamous-cell skin cancer, radically resected local prostate cancer, and radically resected ductal carcinoma in situ of the breast;
  • History of acute or chronic pancreatitis, pancreatic injury, or pancreatic surgery;
  • History of acute cholecystitis, cholelithiasis or severe gallbladder polyps within 6 months prior to screening, for which the investigator assesses that study participation may increase the participant's risk;
  • History of dysphagia or any gastrointestinal disorder affecting drug absorption;
  • Cardiovascular, respiratory, hepatic, gastrointestinal (including disorders markedly affecting gastric emptying or gastric motility, e.g. severe gastric spasm or pyloric stenosis), endocrine (including but not limited to history of thyroid carcinoma or preneoplastic lesions), hematological, neurological diseases, or muscular degenerative disorders that may significantly affect drug absorption, metabolism or elimination, increase participant risk, or confound data interpretation;
  • History of severe hypoglycemic coma; or ≥3 episodes of blood glucose <3.9 mmol/L within any one week in the 2 months before screening (regardless of symptoms); or ≥1 episode of severe hypoglycemia per month within 2 months before screening (blood glucose <3.0 mmol/L accompanied by cognitive impairment or requiring third-party assistance);
  • History of severe psychiatric disorders (including but not limited to suicidal ideation or suicide attempt, schizophrenia, bipolar disorder); or Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening;
  • Severe infection, trauma or major surgical operation within 4 weeks prior to screening; or planned surgical procedure during the study;
  • History of bariatric surgery for obesity;
  • Use of dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1, GCG, GIP or amylin-targeted agents (e.g. exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, mazdutide, etc.) within 2 months before drug administration; or prior intolerance to the above-mentioned agents;
  • Use of any medicinal products within 14 days or 5 half-lives (whichever is longer) prior to drug administration; and planned use of any medicinal products (prescription, over-the-counter, herbal medicines) and/or dietary supplements during the study;
  • Abnormal findings with clinical significance as judged by the investigator in physical examination, vital signs, 12-lead electrocardiogram, or abdominal ultrasound at screening (mild-to-moderate fatty liver is excluded);
  • Any clinically significant laboratory abnormality meeting any of the following criteria at screening:
  • Hepatic impairment: serum ALT or AST >1.5 × upper limit of normal (ULN), or total serum bilirubin >1 × ULN;
  • Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m²;
  • Fasting blood glucose ≥7 mmol/L or <3.9 mmol/L; or HbA1c ≥6.5%;
  • Fasting triglycerides ≥4.5 mmol/L;
  • Hemoglobin <110 g/L for male participants, <100 g/L for female participants;
  • International normalized ratio (INR) >1.3;
  • Serum calcitonin ≥20 pg/mL (i.e. 20 ng/L);
  • Clinically significant abnormalities in thyroid function tests at screening;
  • Positive hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody at screening, or findings judged clinically meaningful by the investigator;
  • Any laboratory abnormality of clinical significance that, in the investigator's opinion, may interfere with evaluation of study results;
  • Blood loss or blood donation exceeding 400 mL, or receipt of blood or blood-component transfusion within 3 months before drug administration; or planned blood donation during the study;
  • Vaccination within 1 month prior to screening, or planned vaccination during the study;
  • Alcohol and tobacco overuse: average alcohol intake ≥14 standard units per week within 6 months before screening (1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); average daily cigarette consumption ≥5 cigarettes, and inability to abstain during the study; positive blood alcohol test or result >0 mg/100 mL;
  • Consumption of special diets (including grapefruit, pomelo, etc.) or strenuous exercise within 14 days before drug administration; or intake of chocolate, any caffeine- or xanthine-containing food or beverages within 48 hours before drug administration; or other factors at screening that may affect drug absorption, distribution, metabolism or excretion;
  • History of drug abuse or illicit-drug use within 1 year prior to drug administration; or positive urine drug screen;
  • Female participants who are pregnant or lactating;
  • Intolerance to venipuncture; or history of vasovagal reaction to injection or blood;
  • Inability to maintain consistent diet and physical activity during the study; or special dietary requirements preventing compliance with standardized study diet;
  • Participation in another clinical trial within 3 months prior to drug administration (excluding screening-only participation without study drug administration or non-interventional studies);
  • Other conditions that, in the investigator's opinion, may affect PK assessment, may prevent the participant from completing the study, may expose the participant to substantial risk from study participation, or otherwise render the participant unsuitable or unable to participate in this study.

Treatment and study plan

UBT251

Drug

Subcutaneous injection administered once weekly with dose escalation

Metformin Hydrochloride

Drug

Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.

Warfarin sodium

Drug

Oral administration. Warfarin sodium will be given as 2 single doses.

Atorvastatin calcium

Drug

Oral administration. Atorvastatin calcium will be given as 2 single doses.

Digoxin

Drug

Oral administration. Digoxin will be given as 2 single doses.

Primary outcomes

  1. Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)

    Time frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses

    Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.

  2. Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin

    Time frame: From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses

    Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of metformin in Cohort 1

    Time frame: Up to 30 hours following last dose at steady-state

    Peak plasma concentration (Cmax) of metformin at steady-state in Cohort 1

  2. Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1

    Time frame: Up to 30 hours following last dose at steady-state

    Time to reach peak plasma concentration (Tmax) of metformin at steady-state in Cohort 1

  3. Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1

    Time frame: Pre-dose and up to 30 hours following last dose at steady-state

    Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of metformin at steady-state in Cohort 1

  4. Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1

    Time frame: Pre-dose and up to 30 hours following last dose at steady-state

    Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) of metformin at steady-state in Cohort 1

  5. Apparent volume of distribution (Vz/F) of metformin in Cohort 1

    Time frame: Pre-dose and up to 30 hours following last dose at steady-state

    Apparent volume of distribution (Vz/F) of metformin at steady-state in Cohort 1

  6. Apparent total clearance (CL/F) of metformin in Cohort 1

    Time frame: Up to 30 hours following last dose at steady-state

    Apparent total clearance (CL/F) of metformin at steady-state in Cohort 1

  7. Terminal elimination rate constant (λz) of metformin in Cohort 1

    Time frame: Pre-dose and up to 30 hours following last dose at steady-state

    Terminal elimination rate constant (λz) of metformin at steady-state in Cohort 1

  8. Terminal half-life (t1/2z) of metformin in Cohort 1

    Time frame: Pre-dose and up to 30 hours following last dose at steady-state

    Terminal elimination half-life (t1/2z) of metformin at steady-state in Cohort 1

  9. Peak Plasma Concentration (Cmax) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).

  10. Time to Maximum Plasma Concentration (Tmax) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).

  11. Terminal Rate Constant (λz) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).

  12. Terminal Half-Life (t1/2z) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).

  13. Apparent Clearance (CL/F) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).

  14. Apparent Volume of Distribution (Vz/F) of S-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of S-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).

  15. Maximum Plasma Concentration (Cmax) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates maximum plasma concentration (Cmax).

  16. Time to Maximum Plasma Concentration (Tmax) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates time to maximum plasma concentration (Tmax).

  17. Terminal Rate Constant (λz) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal rate constant (λz).

  18. Terminal Half-Life (t1/2z) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates terminal half-life (t1/2z).

  19. Apparent Clearance (CL/F) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent clearance (CL/F).

  20. Apparent Volume of Distribution (Vz/F) of R-warfarin in Cohort 1

    Time frame: Pre-dose and up to 168 hours following last dose at steady-state

    Plasma concentrations of R-warfarin will be measured in samples collected pre-dose and up to 168 hours following the last dose at steady-state. This endpoint evaluates apparent volume of distribution (Vz/F).

  21. Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).

  22. Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state time to maximum plasma concentration (Tmax).

  23. Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).

  24. Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).

  25. Terminal Rate Constant (λz) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).

  26. Terminal Half-Life (t1/2z) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).

  27. Apparent Clearance (CL/F) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).

  28. Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 1

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).

  29. Maximum Plasma Concentration (Cmax) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).

  30. Time to Maximum Plasma Concentration (Tmax) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).

  31. Terminal Rate Constant (λz) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).

  32. Terminal Half-Life (t1/2z) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).

  33. Apparent Clearance (CL/F) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent clearance (CL/F).

  34. Apparent Volume of Distribution (Vz/F) of Atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).

  35. Maximum Plasma Concentration (Cmax) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).

  36. Time to Maximum Plasma Concentration (Tmax) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).

  37. Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).

  38. Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).

  39. Terminal Rate Constant (λz) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).

  40. Terminal Half-Life (t1/2z) of 2-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 2-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).

  41. Maximum Plasma Concentration (Cmax) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates maximum plasma concentration (Cmax).

  42. Time to Maximum Plasma Concentration (Tmax) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).

  43. Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to last measurable time-point (AUC0-t).

  44. Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC0-∞) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates area under the concentration-time curve from zero to infinity (AUC0-∞).

  45. Terminal Rate Constant (λz) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal rate constant (λz).

  46. Terminal Half-Life (t1/2z) of 4-hydroxy-atorvastatin in Cohort 2

    Time frame: Pre-dose and up to 72 hours following single dose

    Plasma concentrations of 4-hydroxy-atorvastatin will be measured in samples collected pre-dose and up to 72 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).

  47. Time to Maximum Plasma Concentration (Tmax) of Digoxin in Cohort 2

    Time frame: Pre-dose and up to 120 hours following single dose

    Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates time to maximum plasma concentration (Tmax).

  48. Terminal Rate Constant (λz) of Digoxin in Cohort 2

    Time frame: Pre-dose and up to 120 hours following single dose

    Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal rate constant (λz).

  49. Terminal Half-Life (t1/2z) of Digoxin in Cohort 2

    Time frame: Pre-dose and up to 120 hours following single dose

    Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates terminal half-life (t1/2z).

  50. Apparent Clearance (CL/F) of Digoxin in Cohort 2

    Time frame: Pre-dose and up to 120 hours following single dose

    Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent clearance (CL/F).

  51. Apparent Volume of Distribution (Vz/F) of Digoxin in Cohort 2

    Time frame: Pre-dose and up to 120 hours following single dose

    Plasma concentrations of digoxin will be measured in samples collected pre-dose and up to 120 hours following single dose. This endpoint evaluates apparent volume of distribution (Vz/F).

  52. Maximum Plasma Concentration (Cmax) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state maximum plasma concentration (Cmax).

  53. Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Time to Maximum Plasma Concentration (Tmax) of UBT251 in Cohort 2

  54. Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Time-point (AUC0-t) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve from zero to last measurable time-point (AUC0-t).

  55. Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUC0-τ) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state area under the concentration-time curve over dosing interval (AUC0-τ).

  56. Terminal Rate Constant (λz) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal rate constant (λz).

  57. Terminal Half-Life (t1/2z) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state terminal half-life (t1/2z).

  58. Apparent Clearance (CL/F) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent clearance (CL/F).

  59. Apparent Volume of Distribution (Vz/F) of UBT251 in Cohort 2

    Time frame: Pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing

    Plasma concentrations of UBT251 will be measured in samples collected pre-dose and up to 672 hours following the final dose of UBT251 steady-state dosing. This endpoint evaluates steady-state apparent volume of distribution (Vz/F).

  60. Area Under the INR-Time Curve (AUCINR) of Warfarin Under UBT251 Steady-State in Cohort 2

    Time frame: Baseline to 168 hours

    Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin, when administered under UBT251 steady-state conditions. This endpoint evaluates area under the INR-time curve (AUCINR).

  61. Maximum Observed INR (INRmax) of Warfarin Under UBT251 Steady-State in Cohort 2

    Time frame: Baseline to 168 hours

    Serial INR measurements are collected to characterize the pharmacodynamic effect of warfarin administered under UBT251 steady-state conditions. This endpoint evaluates maximum observed INR (INRmax).

  62. Change in Body Weight From Pre-treatment Baseline Following UBT251 Dosing in Cohort 2

    Time frame: throughout UBT251 titration period

    Body weight is measured at baseline and scheduled visits. This endpoint evaluates body weight change relative to pre-UBT251 baseline.

  63. Incidence, Maximum Severity Grade, and Duration of Adverse Events and Serious Adverse Events During UBT251 Treatment

    Time frame: Baseline up to Study Day 190

    All adverse events and serious adverse events are actively monitored and recorded throughout the study. This outcome assesses the incidence defined as percentage of affected subjects, maximum severity grade classified according to CTCAE criteria, and duration in days of each adverse event.

  64. Changes From Baseline in Vital Signs During UBT251 Treatment

    Time frame: Baseline up to Study Day 190

    Vital signs including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature are measured using standard clinical equipment at scheduled visits. This outcome evaluates absolute and relative changes from baseline throughout the study period.

  65. Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters During UBT251 Treatment

    Time frame: Baseline up to Study Day 190

    12-lead ECGs are collected at scheduled visits and can be additionally performed at any time for safety monitoring. Participants rest in a supine position for at least 5 minutes before testing. Assessed parameters include RR interval, PR interval, heart rate, QRS interval, QT interval, QTc interval, and QTcF calculated by Fredericia's formula. This outcome evaluates parameter changes from baseline and clinically significant abnormal ECG findings.

  66. Clinically Significant Abnormal Findings on Complete Physical Examination During UBT251 Treatment

    Time frame: Baseline up to Study Day 190

    Complete physical examinations are performed at scheduled study visits, covering general condition, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, spine, and extremities. This outcome summarizes all clinically significant abnormal physical examination findings compared with baseline throughout the study period.

  67. Changes From Baseline in Safety Laboratory Parameters During UBT251 Treatment

    Time frame: Baseline up to Study Day 190

    Safety laboratory tests include hematology, urinalysis, serum biochemistry, electrolytes, blood glucose, blood lipids, cardiac enzymes, lipase, amylase, coagulation function, glycated hemoglobin, procalcitonin, thyroid function tests, and infectious disease screening. This outcome evaluates changes from baseline and clinically significant laboratory abnormalities.

  68. Incidence of Positive Anti-UBT251 Binding Antibodies in Subjects Receiving UBT251

    Time frame: Baseline up to Study Day 190

    Validated immunoassay is used as the measurement tool to detect anti-UBT251 binding antibodies. This outcome assesses incidence (percentage of subjects with positive binding antibodies) at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.

  69. Antibody Titer Level of Anti-UBT251 Binding Antibodies in Antibody-Positive Subjects

    Time frame: Baseline up to Study Day 190

    Validated immunoassay is used as the measurement tool to determine antibody titer. This outcome reports titer levels for specimens confirmed positive for anti-UBT251 binding antibodies at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.

  70. Incidence of Positive Anti-UBT251 Neutralizing Antibodies (If Applicable) in Subjects Receiving UBT251

    Time frame: Baseline up to Study Day 190

    Validated cell-based neutralizing antibody assay is used as the measurement tool. This outcome assesses incidence (percentage of subjects with positive neutralizing antibodies), if applicable, at scheduled sampling time-points including Study Day 15, 43, 127, 162 and 190.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Hu, PhD

CONTACT

[email protected]

+86-13856086475

Sponsors and collaborators

Lead sponsor

The United Bio-Technology (Hengqin) Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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