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Completed

NCT Number: NCT05917782

A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.

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Key information

Conditions

Healthy Adult Subjects

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, 230000, China

About this study

A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201 injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201 injection (vial, 150 mg/1 mL)), respectively.

The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who are to read, understand, and sign the ICF.
  • Healthy adult male or female subjects aged 18-45 years (inclusive) at screening, with each sex accounting for at least one-third of the overall sample size.
  • Body mass index (BMI) is between 19 and 28 kg/m2 (inclusive). Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg.
  • Subjects with partners must agree to take medically accepted effective contraceptive measures (including physical contraception, surgery, abstinence, etc) from signing of the ICF until 90 days after administration.
  • The results of vital sign assessment, physical examination, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation) and 12-lead ECG at screening or baseline are normal or abnormal but not clinically significant.
  • Subjects who are able to communicate well with the clinical staff and complete the study according to the protocol.

Exclusion criteria

  • Subjects who have diseases or conditions with abnormal clinical manifestations, including but not limited to renal, cardiac, hematological, bronchial, pulmonary, vascular, gastrointestinal, allergic, neurological, endocrine and metabolic diseases (diabetes mellitus, thyroid disorder, and adrenal disorder), skeletal disease and immunodeficiency, cancer, and hepatitis, or cirrhosis.
  • Subjects with allergic diseases (such as allergic rhinitis, allergic asthma) at screening, a history of systemic anaphylaxis, or who may be allergic to any component of the test drugs or similar drugs as determined by the investigator.
  • Subjects who have donated blood or have had substantial loss of blood (> 400 mL) within 3 months before administration.
  • Subjects who have been vaccinated with live (attenuated) vaccines within 3 months before administration.
  • Subjects who have participated in clinical studies of other drugs within 3 months before administration.
  • Subjects who have taken any prescription drugs, over-the-counter drugs, vitamin products, Chinese patent medicines, and Chinese herbal medicines within 1 month before administration.
  • Subjects who have been diagnosed with clinically significant diseases or have undergone major surgical procedures within 1 month before administration, or who are scheduled to undergo major surgery during the study.
  • Female subjects who test positive for pregnancy at screening or baseline or who are lactating.
  • Subjects who smoke more than 5 cigarettes or equivalent per day within 3 months before administration.
  • Subjects who have a history of drug abuse within the last 5 years, who have used narcotics within 3 months before administration, or who test positive in urine drug screening at the screening/baseline visit.
  • Subjects who have a history of regular alcohol consumption, which is defined as consumption of more than 7 units of alcohol per week for females or more than 14 units of alcohol per week for males (1 unit of alcohol equals 360 mL of beer, 45 mL of 40% liquor, or 150 mL of wine) within 3 months before administration, who take any alcohol-containing product within 48 h before administration, or who test positive in blood alcohol tests at the screening/ baseline visit.
  • Subjects with known symptoms of dermatitis or skin abnormalities at and around the site of administration.
  • Subjects who test positive for treponema pallidum antibody (TP-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab).
  • Patients with active tuberculosis, latent tuberculosis, or nontuberculous mycobacterial infection at screening;

Notes:

  • Unless treatment records clearly documented by a specialist demonstrate that the patients have been adequately treated and may begin treatment with biological product (based on the medical judgment by the investigator and/or infectious disease specialist);
  • If needed, T-spot tests may be used to assist diagnosis of suspected tuberculosis.
  • Subjects with white blood cell count and neutrophil count below the lower limit of normal.
  • Female subjects with hemoglobin values less than 110 g/L or male subjects less than 120 g/L.
  • Subjects who cannot tolerate venous blood sampling, or who have a history of acupuncture syncope or hemophobia.
  • Subjects who still need or plan to engage in strenuous physical activity or exercise during the study.
  • Any other conditions that the investigator determines may affect the subject's provision of informed consent or compliance with the study protocol, or that the investigator deems unsuitable for participation in this study, or the subjects' participation in the study may affect the study results or their own safety.

Treatment and study plan

Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)

Biological

subcutaneous injection of 2 doses on Day 1

Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)

Biological

subcutaneous injection of 1 dose on Day 1

Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)

Biological

subcutaneous injection of 2 doses on Day 1

Primary outcomes

  1. Cmax: Maximum concentration

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

  2. AUC0-t: Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

  3. AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  2. Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T (AUC0-t)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  3. Area under the plasma concentration-time curve from the start of administration to infinity (AUC0-inf)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  4. Time to peak (Tmax)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  5. Elimination half-life (t1/2)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  6. Apparent clearance (CL/F)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  7. Apparent volume of distribution (Vz/F)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  8. Terminal elimination phase rate constant (λz)

    Time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

  9. Adverse events (AEs)

    Time frame: Up to 57 days post dosing

    All adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) (the latest version).

  10. Injection site reactions

    Time frame: Day1, Day2, Day3, Day4, Day6, Day8, Day15, Day22, Day29, Day57

    The injection site will be examined and the results will be judged by the investigator.

  11. Blood Pressure (systolic and diastolic blood pressures)

    Time frame: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

  12. Pulse

    Time frame: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

  13. Body Temperature (ear temperature)

    Time frame: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

  14. Respiratory Rate

    Time frame: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

  15. Physical examination

    Time frame: pre-dose, Day6, Day15, Day29, Day57

    Physical examination items include: skin (including observation of the planned injection site (abdomen) and surrounding skin during the screening period and at baseline), lymph nodes, head, eyes, neck, chest, abdomen, spine/extremities, and nervous system. The results of physical examination will be evaluated by investigator's observation.

  16. 12-lead electrocardiogram (ECG)

    Time frame: pre-dose, Day1, Day2, Day4, Day6, Day10, Day15, Day22, Day29, Day36, Day43, Day57

    ECG variables include ventricular heart rate, PR interval, QRS interval, QT interval, and QTcF interval.

  17. Clinical laboratory test: Hematology - Hemoglobin (Hgb)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  18. Clinical laboratory test: Hematology - Hematocrit (Hct)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  19. Clinical laboratory test: Hematology - red blood cell count (RBC)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  20. Clinical laboratory test: Hematology - platelet count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  21. Clinical laboratory test: Hematology - white blood cell count (WBC)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  22. Clinical laboratory test: Hematology - lymphocyte count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  23. Clinical laboratory test: Hematology - lymphocyte percentage

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  24. Clinical laboratory test: Hematology - neutrophil count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  25. Clinical laboratory test: Hematology - neutrophil percentage

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  26. Clinical laboratory test: Hematology - monocyte count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  27. Clinical laboratory test: Hematology - monocyte percentage

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  28. Clinical laboratory test: Hematology - eosinophil count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  29. Clinical laboratory test: Hematology - eosinophil percentage

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  30. Clinical laboratory test: Hematology - basophil count

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  31. Clinical laboratory test: Hematology - basophil percentage

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  32. Clinical laboratory test: Hematology - mean corpuscular hemoglobin (MCH)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  33. Clinical laboratory test: Hematology - mean corpuscular volume (MCV)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  34. Clinical laboratory test: Urinalysis

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    Urine protein, cast, urine red blood cells, urine white blood cells, urine pH, urine ketone body, glucose urine, urine bilirubin, and urine occult blood

  35. Clinical laboratory test: Biochemistry - Glucose (Glu)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  36. Clinical laboratory test: Biochemistry - alanine aminotransferase (ALT)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  37. Clinical laboratory test: Biochemistry - aspartate aminotransferase (AST)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  38. Clinical laboratory test: Biochemistry - alkaline phosphatase (ALP)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  39. Clinical laboratory test: Biochemistry - lactate dehydrogenase (LDH)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  40. Clinical laboratory test: Biochemistry - gamma-glutamyltransferase (γ-GGT)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  41. Clinical laboratory test: Biochemistry - serum total protein (TP)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  42. Clinical laboratory test: Biochemistry - albumin (ALB)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  43. Clinical laboratory test: Biochemistry - total bilirubin (TBIL)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  44. Clinical laboratory test: Biochemistry - direct bilirubin (DBIL)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  45. Clinical laboratory test: Biochemistry - blood urea nitrogen (BUN)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  46. Clinical laboratory test: Biochemistry - creatinine (Crea)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  47. Clinical laboratory test: Biochemistry - sodium (Na)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  48. Clinical laboratory test: Biochemistry - potassium (K)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  49. Clinical laboratory test: Biochemistry - chlorine (Cl)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  50. Clinical laboratory test: Biochemistry - calcium (Ca)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  51. Clinical laboratory test: Biochemistry - phosphorus (P)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  52. Clinical laboratory test: Biochemistry - triglycerides (TG)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  53. Clinical laboratory test: Biochemistry - total cholesterol (TC)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  54. Clinical laboratory test: Biochemistry - high-density lipoprotein cholesterol (HDL-C)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  55. Clinical laboratory test: Biochemistry - low-density lipoprotein cholesterol (LDL-C)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  56. Clinical laboratory test: Biochemistry - uric acid (UA)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  57. Clinical laboratory test: Biochemistry - creatine kinase (CK)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  58. Clinical laboratory test: Coagulation - International normalized ratio (INR)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  59. Clinical laboratory test: Coagulation - prothrombin time (PT)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  60. Clinical laboratory test: Coagulation - activated partial thromboplastin time (APTT)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  61. Clinical laboratory test: Coagulation - fibrinogen (FIB)

    Time frame: pre-dose, Day6, Day15, Day29, Day43, Day57

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

  62. Clinical laboratory test: Pregnancy test

    Time frame: pre-dose, Day15, Day29, Day43, Day57

    Blood pregnancy test (for females only)

  63. Clinical laboratory test: Infectious serology

    Time frame: pre-dose

    Hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, Treponema pallidum antibody, and human immunodeficiency virus antibody

  64. Clinical laboratory test: Blood alcohol test

    Time frame: pre-dose

    Blood alcohol test

  65. Clinical laboratory test: Urine drug abuse screening

    Time frame: pre-dose

    Morphine, methamphetamine, ketamine, methylenedioxy methylamphetamine, marijuana, and cocaine

  66. T-Spot

    Time frame: pre-dose

    If necessary, T-spot screening can be performed for priorly infected or suspected patients

  67. Immunogenicity: The positive rate and titer of anti-drug antibody (ADA), and the positive rate of neutralizing antibody (Nab, in case of ADA positive results)

    Time frame: pre-dose, Day11, Day29, Day43, Day57

    Immunogenicity will be analyzed based on IMS. The number and percentage of subjects positive for CBP-201 ADA and Nab will be summarized by dose group.

Sponsors and collaborators

Lead sponsor

Connect Biopharm LLC

Industry

Registry information

Official study title

A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Oct 31, 2023

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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