Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults
- Registration Number
- NCT05842798
- Lead Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Healthy male or female, 18-55 years of age;
- Body mass index (BMI) within 19.0-26.0 kg/m2;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: TNM002 35 μg/kg or placebo TNM002 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) Cohort 2: TNM002 100 μg/kg or placebo TNM002 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) Cohort 2: TNM002 100 μg/kg or placebo 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) Cohort 3：TNM002 250 μg/kg or placebo TNM002 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) Cohort 3：TNM002 250 μg/kg or placebo 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) Cohort 1: TNM002 35 μg/kg or placebo 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)
- Primary Outcome Measures
Name Time Method Change in Red blood cell count (cells x 10^12/L) Up to 105 days post dosing Measured by hematology test
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 Platelet count (cells x 10^9/L) Up to 105 days post dosing Measured by hematology test
Change in Urine Bilirubin (U-BIL) Up to 105 days post dosing Measured by Urinalysis
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 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 Serum Alkaline Phosphatase (ALP) (U/L) Up to 105 days post dosing Measured by serum chemistry
Change in differential leukocyte count (cells x 10^9/L) Up to 105 days post dosing Measured by hematology test
Change in Serum Total Bilirubin (umol/L) Up to 105 days post dosing Measured by serum chemistry
Change in Serum Alanine Aminotransferase (ALT) (U/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 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 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 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 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
Name Time Method 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 percentages of subjects who developed anti-TNM002 antibodies
Trial Locations
- Locations (1)
The Fifth Affiliated Hospital Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China