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Completed

NCT Number: NCT05842798

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Fifth Affiliated Hospital Sun Yat-sen University

Zhuhai, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female, 18-55 years of age;
  • Body mass index (BMI) within 19.0-26.0 kg/m2;

Exclusion criteria

  • Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
  • Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
  • History of alcohol or other substance abuse.

Treatment and study plan

TNM002

Drug

TNM002, intramuscular injection

Placebo

Drug

Placebo, intramuscular injection

Primary outcomes

  1. AEs

    Time frame: Up to 105 days post dosing

    Incidence of AEs

  2. Number of participants with clinically significant abnormality in physical examinations

    Time frame: Up to 105 days post dosing

    Clinically significant abnormality in general condition, skin, eyes/ears/nose/mouth/throat, neck/thyroid, chest/lungs, heart, vascular system, lymph nodes, abdomen, extremities, nervous systems/reflexes, musculoskeletal, spine

  3. Change in Hematocrit (ratio)

    Time frame: Up to 105 days post dosing

    Measured by hematology test

  4. Change in Haemoglobin (g/L)

    Time frame: Up to 105 days post dosing

    Measured by hematology test

  5. Change in Platelet count (cells x 10^9/L)

    Time frame: Up to 105 days post dosing

    Measured by hematology test

  6. Change in Red blood cell count (cells x 10^12/L)

    Time frame: Up to 105 days post dosing

    Measured by hematology test

  7. Change in differential leukocyte count (cells x 10^9/L)

    Time frame: Up to 105 days post dosing

    Measured by hematology test

  8. Change in Serum Alanine Aminotransferase (ALT) (U/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  9. Change in Serum Aspartate Aminotransferase (AST) (U/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  10. Change in Serum Albumin (g/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  11. Change in Serum Alkaline Phosphatase (ALP) (U/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  12. Change in Serum Total Bilirubin (umol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  13. Change in Serum Blood urea nitrogen (BUN) (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  14. Change in Serum Creatinine (umol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  15. Change in Serum Calcium (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  16. Change in Serum Chloride (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  17. Change in Serum Cholesterol (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  18. Change in Serum Creatine Kinase (U/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  19. Change in Serum Glucose (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  20. Change in Serum Lactate Dehydrogenase (U/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  21. Change in Serum Phosphorus (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  22. Change in Serum Potassium (mmol/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  23. Change in Serum Total protein (g/L)

    Time frame: Up to 105 days post dosing

    Measured by serum chemistry

  24. Change in Urine Bilirubin (U-BIL)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  25. Change in Urine Glucose (GLU) (mg/dL)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  26. Change in Urine erythrocytes (U-RBC)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  27. Change in Urinary leukocyte (U-LEU)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  28. Change in Urine nitrites (U-NIT)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  29. Change in Urine protein (U-PRO)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  30. Change in Urine specific gravity (U-SG)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  31. Change in Urine urobilinogen (URO)

    Time frame: Up to 105 days post dosing

    Measured by Urinalysis

  32. Change in Prothrombin time (sec)

    Time frame: Up to 105 days post dosing

    Measured by Blood Coagulation test

  33. Change in Activated partial thromboplastin time (APTT)(sec)

    Time frame: Up to 105 days post dosing

    Measured by Blood Coagulation test

  34. Change in fibrinogen (g/L)

    Time frame: Up to 105 days post dosing

    Measured by Blood Coagulation test

  35. Change in international normalized ratio (INR

    Time frame: Up to 105 days post dosing

    Measured by Blood Coagulation test

  36. Change in RR intervals (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  37. Change in PR intervals (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  38. Change in QRS duration (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  39. Change in QT intervals (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  40. Change in QTcB intervals (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  41. Change in QTcF intervals (msec)

    Time frame: Up to 105 days post dosing

    Measured using a 12 Lead Electrocardiogram

  42. Change in blood pressure (mmHg)

    Time frame: Up to 105 days post dosing

  43. Change in pulse rate (bpm)

    Time frame: Up to 105 days post dosing

  44. Change in body temperature (celsius)

    Time frame: Up to 105 days post dosing

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  2. Time of maximum plasma concentration (Tmax)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  3. Terminal half-life (T1/2)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  4. Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  5. Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  6. Apparent total body clearance (CL/F)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  7. Apparent volume of distribution (Vz/F)

    Time frame: Up to 105 days post dosing

    Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;

  8. Anti-TNM002 antibodies

    Time frame: Up to 105 days post dosing

    The numbers of subjects who developed anti-TNM002 antibodies

  9. Anti-TNM002 antibodies

    Time frame: Up to 105 days post dosing

    The percentages of subjects who developed anti-TNM002 antibodies

Other outcomes

  1. Tetanus-antibody titer

    Time frame: Up to 105 days post dosing

    Geometric mean titers (GMTs) of tetanus-antibody titer in serum

  2. Tetanus-antibody titer

    Time frame: Up to 105 days post dosing

    The percentage of subjects with a change of titer > 10 IU/L from the baseline

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 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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