Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: TNM002 35 μg/kg or placebo Eight subjects will be randomly assigned to receive either TNM002 35 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
Drug: TNM002
TNM002, intramuscular injection
Drug: Placebo
Placebo, intramuscular injection
|
| Experimental: Cohort 2: TNM002 100 μg/kg or placebo Eight subjects will be randomly assigned to receive either TNM002 100 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
Drug: TNM002
TNM002, intramuscular injection
Drug: Placebo
Placebo, intramuscular injection
|
| Experimental: Cohort 3：TNM002 250 μg/kg or placebo Eight subjects will be randomly assigned to receive either TNM002 250 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo) |
Drug: TNM002
TNM002, intramuscular injection
Drug: Placebo
Placebo, intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- AEs [Up to 105 days post dosing]
Incidence of AEs
- Number of participants with clinically significant abnormality in physical examinations [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
- Change in Hematocrit (ratio) [Up to 105 days post dosing]
Measured by hematology test
- Change in Haemoglobin (g/L) [Up to 105 days post dosing]
Measured by hematology test
- Change in Platelet count (cells x 10^9/L) [Up to 105 days post dosing]
Measured by hematology test
- Change in Red blood cell count (cells x 10^12/L) [Up to 105 days post dosing]
Measured by hematology test
- Change in differential leukocyte count (cells x 10^9/L) [Up to 105 days post dosing]
Measured by hematology test
- Change in Serum Alanine Aminotransferase (ALT) (U/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Aspartate Aminotransferase (AST) (U/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Albumin (g/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Alkaline Phosphatase (ALP) (U/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Total Bilirubin (umol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Blood urea nitrogen (BUN) (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Creatinine (umol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Calcium (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Chloride (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Cholesterol (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Creatine Kinase (U/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Glucose (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Lactate Dehydrogenase (U/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Phosphorus (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Potassium (mmol/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Serum Total protein (g/L) [Up to 105 days post dosing]
Measured by serum chemistry
- Change in Urine Bilirubin (U-BIL) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine Glucose (GLU) (mg/dL) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine erythrocytes (U-RBC) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urinary leukocyte (U-LEU) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine nitrites (U-NIT) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine protein (U-PRO) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine specific gravity (U-SG) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Urine urobilinogen (URO) [Up to 105 days post dosing]
Measured by Urinalysis
- Change in Prothrombin time (sec) [Up to 105 days post dosing]
Measured by Blood Coagulation test
- Change in Activated partial thromboplastin time (APTT)(sec) [Up to 105 days post dosing]
Measured by Blood Coagulation test
- Change in fibrinogen (g/L) [Up to 105 days post dosing]
Measured by Blood Coagulation test
- Change in international normalized ratio (INR [Up to 105 days post dosing]
Measured by Blood Coagulation test
- Change in RR intervals (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in PR intervals (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in QRS duration (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in QT intervals (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in QTcB intervals (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in QTcF intervals (msec) [Up to 105 days post dosing]
Measured using a 12 Lead Electrocardiogram
- Change in blood pressure (mmHg) [Up to 105 days post dosing]
- Change in pulse rate (bpm) [Up to 105 days post dosing]
- Change in body temperature (celsius) [Up to 105 days post dosing]
Secondary Outcome Measures
- Maximum observed plasma concentration (Cmax) [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;
- Time of maximum plasma concentration (Tmax) [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;
- Terminal half-life (T1/2) [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;
- Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) [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;
- Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf) [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;
- Apparent total body clearance (CL/F) [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;
- Apparent volume of distribution (Vz/F) [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;
- Anti-TNM002 antibodies [Up to 105 days post dosing]
The numbers of subjects who developed anti-TNM002 antibodies
- Anti-TNM002 antibodies [Up to 105 days post dosing]
The percentages of subjects who developed anti-TNM002 antibodies
Other Outcome Measures
- Tetanus-antibody titer [Up to 105 days post dosing]
Geometric mean titers (GMTs) of tetanus-antibody titer in serum
- Tetanus-antibody titer [Up to 105 days post dosing]
The percentage of subjects with a change of titer > 10 IU/L from the baseline
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Fifth Affiliated Hospital Sun Yat-sen University | Zhuhai | Guangdong | China |
Sponsors and Collaborators
- Trinomab Biotech Co., Ltd.
Investigators
- Principal Investigator: Zhigang Liu, The Fifth Affiliated Hospital Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TNM002-P1-CH01