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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
28
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, China
AEs
Incidence of AEs
Time frame: Up to 105 days post dosing
Number of participants with clinically significant abnormality in physical examinations
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
Time frame: Up to 105 days post dosing
Change in Hematocrit (ratio)
Measured by hematology test
Time frame: Up to 105 days post dosing
Change in Haemoglobin (g/L)
Measured by hematology test
Time frame: Up to 105 days post dosing
Change in Platelet count (cells x 10^9/L)
Measured by hematology test
Time frame: Up to 105 days post dosing
Change in Red blood cell count (cells x 10^12/L)
Measured by hematology test
Time frame: Up to 105 days post dosing
Change in differential leukocyte count (cells x 10^9/L)
Measured by hematology test
Time frame: Up to 105 days post dosing
Change in Serum Alanine Aminotransferase (ALT) (U/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Aspartate Aminotransferase (AST) (U/L)
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Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Albumin (g/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Alkaline Phosphatase (ALP) (U/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Total Bilirubin (umol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Creatinine (umol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Calcium (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Chloride (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Cholesterol (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Creatine Kinase (U/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Glucose (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Lactate Dehydrogenase (U/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Phosphorus (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Potassium (mmol/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Serum Total protein (g/L)
Measured by serum chemistry
Time frame: Up to 105 days post dosing
Change in Urine Bilirubin (U-BIL)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine Glucose (GLU) (mg/dL)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine erythrocytes (U-RBC)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urinary leukocyte (U-LEU)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine nitrites (U-NIT)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine protein (U-PRO)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine specific gravity (U-SG)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Urine urobilinogen (URO)
Measured by Urinalysis
Time frame: Up to 105 days post dosing
Change in Prothrombin time (sec)
Measured by Blood Coagulation test
Time frame: Up to 105 days post dosing
Change in Activated partial thromboplastin time (APTT)(sec)
Measured by Blood Coagulation test
Time frame: Up to 105 days post dosing
Change in fibrinogen (g/L)
Measured by Blood Coagulation test
Time frame: Up to 105 days post dosing
Change in international normalized ratio (INR
Measured by Blood Coagulation test
Time frame: Up to 105 days post dosing
Change in RR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in PR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in QRS duration (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in QT intervals (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in QTcB intervals (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in QTcF intervals (msec)
Measured using a 12 Lead Electrocardiogram
Time frame: Up to 105 days post dosing
Change in blood pressure (mmHg)
Time frame: Up to 105 days post dosing
Change in pulse rate (bpm)
Time frame: Up to 105 days post dosing
Change in body temperature (celsius)
Time frame: Up to 105 days post dosing
Maximum observed plasma concentration (Cmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Time of maximum plasma concentration (Tmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Terminal half-life (T1/2)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Apparent total body clearance (CL/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Apparent volume of distribution (Vz/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
Time frame: Up to 105 days post dosing
Anti-TNM002 antibodies
The numbers of subjects who developed anti-TNM002 antibodies
Time frame: Up to 105 days post dosing
Anti-TNM002 antibodies
The percentages of subjects who developed anti-TNM002 antibodies
Time frame: Up to 105 days post dosing