Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842798
• Other study ID #: TNM002-P1-CH01
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2023
• Source: Trinomab Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy male or female, 18-55 years of age;

2. Body mass index (BMI) within 19.0-26.0 kg/m2;

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;

2. Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;

3. History of alcohol or other substance abuse.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TNM002
TNM002, intramuscular injection
• Placebo
Placebo, intramuscular injection

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Trinomab Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tetanus-antibody titer	Geometric mean titers (GMTs) of tetanus-antibody titer in serum	Up to 105 days post dosing
Other	Tetanus-antibody titer	The percentage of subjects with a change of titer > 10 IU/L from the baseline	Up to 105 days post dosing
Primary	AEs	Incidence of AEs	Up to 105 days post dosing
Primary	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
Primary	Change in Hematocrit (ratio)	Measured by hematology test	Up to 105 days post dosing
Primary	Change in Haemoglobin (g/L)	Measured by hematology test	Up to 105 days post dosing
Primary	Change in Platelet count (cells x 10^9/L)	Measured by hematology test	Up to 105 days post dosing
Primary	Change in Red blood cell count (cells x 10^12/L)	Measured by hematology test	Up to 105 days post dosing
Primary	Change in differential leukocyte count (cells x 10^9/L)	Measured by hematology test	Up to 105 days post dosing
Primary	Change in Serum Alanine Aminotransferase (ALT) (U/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Aspartate Aminotransferase (AST) (U/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Albumin (g/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Alkaline Phosphatase (ALP) (U/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Total Bilirubin (umol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Blood urea nitrogen (BUN) (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Creatinine (umol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Calcium (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Chloride (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Cholesterol (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Creatine Kinase (U/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Glucose (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Lactate Dehydrogenase (U/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Phosphorus (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Potassium (mmol/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Serum Total protein (g/L)	Measured by serum chemistry	Up to 105 days post dosing
Primary	Change in Urine Bilirubin (U-BIL)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine Glucose (GLU) (mg/dL)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine erythrocytes (U-RBC)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urinary leukocyte (U-LEU)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine nitrites (U-NIT)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine protein (U-PRO)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine specific gravity (U-SG)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Urine urobilinogen (URO)	Measured by Urinalysis	Up to 105 days post dosing
Primary	Change in Prothrombin time (sec)	Measured by Blood Coagulation test	Up to 105 days post dosing
Primary	Change in Activated partial thromboplastin time (APTT)(sec)	Measured by Blood Coagulation test	Up to 105 days post dosing
Primary	Change in fibrinogen (g/L)	Measured by Blood Coagulation test	Up to 105 days post dosing
Primary	Change in international normalized ratio (INR	Measured by Blood Coagulation test	Up to 105 days post dosing
Primary	Change in RR intervals (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in PR intervals (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in QRS duration (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in QT intervals (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in QTcB intervals (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in QTcF intervals (msec)	Measured using a 12 Lead Electrocardiogram	Up to 105 days post dosing
Primary	Change in blood pressure (mmHg)		Up to 105 days post dosing
Primary	Change in pulse rate (bpm)		Up to 105 days post dosing
Primary	Change in body temperature (celsius)		Up to 105 days post dosing
Secondary	Maximum observed plasma concentration (Cmax)	Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	Time of maximum plasma concentration (Tmax)	Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	Terminal half-life (T1/2)	Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	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, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	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, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	Apparent total body clearance (CL/F)	Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	Apparent volume of distribution (Vz/F)	Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above CL/F, Vz/F, MRT, ?z, and %AUCex;	Up to 105 days post dosing
Secondary	Anti-TNM002 antibodies	The numbers of subjects who developed anti-TNM002 antibodies	Up to 105 days post dosing
Secondary	Anti-TNM002 antibodies	The percentages of subjects who developed anti-TNM002 antibodies	Up to 105 days post dosing