Completed
PHASE1
INTERVENTIONAL
NCT04629131
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 healthy adult subjects.
Detailed Description
The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled. After injection (Day 1), participants remain in the study site for observation up to 5 days. Following completion of the safety assessments and sampling for PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15, 29, 43, 64 and 85, participants will return for safety assessments.
Interventions
Name:
TNM002 Dosage 1 (10 μg/kg)
Type:
BIOLOGICAL
Description:
TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once.
Name:
Placebo
Type:
BIOLOGICAL
Description:
placebo to match TNM002 Dosage 1, given once
Name:
TNM002 Dosage 2 (35 μg/kg)
Type:
BIOLOGICAL
Description:
TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once
Name:
Placebo
Type:
BIOLOGICAL
Description:
placebo to match TNM002 Dosage 2, given once
Name:
TNM002 Dosage 3 (100 μg/kg)
Type:
BIOLOGICAL
Description:
TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once
Name:
Placebo
Type:
BIOLOGICAL
Description:
placebo to match TNM002 Dosage 3, given once
Name:
TNM002 Dosage 4 (250 μg/kg)
Type:
BIOLOGICAL
Description:
TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once
Name:
Placebo
Type:
BIOLOGICAL
Description:
placebo to match TNM002 Dosage 4, given once
Primary Outcomes
Measure:
Incidence and severity of adverse events
TimeFrame:
Up to 105 days post dosing
Description:
The investigator will assess the intensity for each AE reported during the study based on the investigator's clinical judgment. Adverse events will be recorded according to CTCAE V5.0.
Measure:
Clinically significant abnormality in physical examinations
TimeFrame:
Up to 105 days post dosing
Description:
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
Measure:
Change in RR intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in PR intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in QRS duration (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in QT intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Calculated using measurements by a 12 Lead Electrocardiogram
Measure:
Change in QTcB intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Calculated using measurements by a 12 Lead Electrocardiogram
Measure:
Change in QTcF intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Calculated using measurements by a 12 Lead Electrocardiogram
Measure:
Change in Semi recumbent blood pressure (mmHg)
TimeFrame:
Up to 105 days post dosing
Description:
Measure:
Change in pulse rate (bpm)
TimeFrame:
Up to 105 days post dosing
Description:
Measure:
Change in body temperature (celsius)
TimeFrame:
Up to 105 days post dosing
Description:
Measure:
Change in Hematocrit (ratio)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Haemoglobin (g/L)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Mean corpuscular hemoglobin (pg)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Mean corpuscular hemoglobin concentration (g/L)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Mean corpuscular volume (fL)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Platelet count (cells x 10^9/L))
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in Red blood cell count (cells x 10^12/L)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in White blood cell count (cells x 10^9/L)
TimeFrame:
Up to 105 days post dosing
Description:
Measured by hematology test
Measure:
Change in differential leukocyte count (cells x 10^9/L)
TimeFrame:
Up to 105 days post dosing
Description:
Including eosinophils, monocytes, lymphocytes, basophils, and neutrophils, Measured by hematology test
Measure:
Change in Serum Alanine Aminotransferase (ALT) (U/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Albumin (g/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Alkaline Phosphatase (ALP) (U/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Aspartate Aminotransferase (AST) (U/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Total Bilirubin (umol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Calcium (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Chloride (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Cholesterol (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Creatinine (umol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Creatine Kinase (U/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Glucose (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Lactate Dehydrogenase (U/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Phosphorus (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Potassium (mmol/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Serum Total protein (g/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by serum chemistry
Measure:
Change in Urine Bilirubin (U-BIL)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine Glucose (GLU) (mg/dL)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine erythrocytes (U-RBC)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urinary leukocyte (U-LEU)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine nitrites (U-NIT)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine protein (U-PRO)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine specific gravity (U-SG)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Urine urobilinogen (URO)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Urinalysis
Measure:
Change in Prothrombin time (sec)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Blood Coagulation test
Measure:
Change in Activated partial thromboplastin time (APTT)(sec)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Blood Coagulation test
Measure:
Change in fibrinogen (g/L)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Blood Coagulation test
Measure:
Change in international normalized ratio (INR)
TimeFrame:
Up to 105 days post dosing
Description:
measured by Blood Coagulation test
Trial Information
NCT ID
NCT04629131
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Last Updated
December 15, 2025