Completed
PHASE1
INTERVENTIONAL
NCT05842798
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese 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 Chinese healthy adults.
Interventions
Name:
TNM002
Type:
DRUG
Description:
TNM002, intramuscular injection
Name:
Placebo
Type:
DRUG
Description:
Placebo, intramuscular injection
Primary Outcomes
Measure:
AEs
TimeFrame:
Up to 105 days post dosing
Description:
Incidence of AEs
Measure:
Number of participants with 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 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 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 differential leukocyte count (cells x 10^9/L)
TimeFrame:
Up to 105 days post dosing
Description:
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 Aspartate Aminotransferase (AST) (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 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 Creatinine (umol/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 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
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:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in QTcB intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in QTcF intervals (msec)
TimeFrame:
Up to 105 days post dosing
Description:
Measured using a 12 Lead Electrocardiogram
Measure:
Change in 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:
Trial Information
NCT ID
NCT05842798
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Last Updated
December 15, 2025