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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TNM002 35 μg/kg or placebo | Experimental | 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 | Experimental | 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 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM002 | Drug | TNM002, intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Incidence of AEs | 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 | Up to 105 days post dosing |
| Change in Hematocrit (ratio) | Measured by hematology test | Up to 105 days post dosing |
| Change in Haemoglobin (g/L) | Measured by hematology test | Up to 105 days post dosing |
| Change in Platelet count (cells x 10^9/L) | Measured by hematology test | Up to 105 days post dosing |
| Change in Red blood cell count (cells x 10^12/L) | Measured by hematology test | Up to 105 days post dosing |
| Change in differential leukocyte count (cells x 10^9/L) | Measured by hematology test | Up to 105 days post dosing |
| Change in Serum Alanine Aminotransferase (ALT) (U/L) |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | Up to 105 days post dosing |
| Time of maximum plasma concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Tetanus-antibody titer | Geometric mean titers (GMTs) of tetanus-antibody titer in serum | Up to 105 days post dosing |
| Tetanus-antibody titer | The percentage of subjects with a change of titer > 10 IU/L from the baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhigang Liu | The Fifth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital Sun Yat-sen University | Zhuhai | Guangdong | China |
Individual participant data that underlie the results reported in these articles after deidentification
Beginning 3 months and ending 5 years following article publication.
Academics who provide a methodologically sound proposal.
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| Placebo | Drug | Placebo, intramuscular injection |
|
Measured by serum chemistry
| Up to 105 days post dosing |
| Change in Serum Aspartate Aminotransferase (AST) (U/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Albumin (g/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Alkaline Phosphatase (ALP) (U/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Total Bilirubin (umol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Blood urea nitrogen (BUN) (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Creatinine (umol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Calcium (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Chloride (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Cholesterol (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Creatine Kinase (U/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Glucose (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Lactate Dehydrogenase (U/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Phosphorus (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Potassium (mmol/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Serum Total protein (g/L) | Measured by serum chemistry | Up to 105 days post dosing |
| Change in Urine Bilirubin (U-BIL) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine Glucose (GLU) (mg/dL) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine erythrocytes (U-RBC) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urinary leukocyte (U-LEU) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine nitrites (U-NIT) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine protein (U-PRO) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine specific gravity (U-SG) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Urine urobilinogen (URO) | Measured by Urinalysis | Up to 105 days post dosing |
| Change in Prothrombin time (sec) | Measured by Blood Coagulation test | Up to 105 days post dosing |
| Change in Activated partial thromboplastin time (APTT)(sec) | Measured by Blood Coagulation test | Up to 105 days post dosing |
| Change in fibrinogen (g/L) | Measured by Blood Coagulation test | Up to 105 days post dosing |
| Change in international normalized ratio (INR | Measured by Blood Coagulation test | Up to 105 days post dosing |
| Change in RR intervals (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| Change in PR intervals (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| Change in QRS duration (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| Change in QT intervals (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| Change in QTcB intervals (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| Change in QTcF intervals (msec) | Measured using a 12 Lead Electrocardiogram | Up to 105 days post dosing |
| 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 |
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, λz, and %AUCex;
| 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; | 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; | 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; | 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; | 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; | Up to 105 days post dosing |
| Anti-TNM002 antibodies | The numbers of subjects who developed anti-TNM002 antibodies | Up to 105 days post dosing |
| Anti-TNM002 antibodies | The percentages of subjects who developed anti-TNM002 antibodies | Up to 105 days post dosing |
| Up to 105 days post dosing |