Healthy Volunteers
Conditions
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.
Interventions
DRUGTNM002
TNM002, intramuscular injection
DRUGPlacebo
Placebo, intramuscular injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female, 18-55 years of age; 2. Body mass index (BMI) within 19.0-26.0 kg/m2;
Exclusion criteria
1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; 2. Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs; 3. History of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body temperature (celsius) | Up to 105 days post dosing | — |
| 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 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 |
| 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 |
| AEs | Up to 105 days post dosing | Incidence of AEs |
| Change in Red blood cell count (cells x 10^12/L) | Up to 105 days post dosing | Measured by hematology test |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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; |
| 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; |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tetanus-antibody titer | Up to 105 days post dosing | Geometric mean titers (GMTs) of tetanus-antibody titer in serum |
Countries
China
Outcome results
None listed