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

NCT05842798 | Completed Phase 1 FDA Drug

• 1 other identifier: TNM002-P1-CH01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (44)

• 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)

  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

Secondary Outcomes (9)

• Maximum observed plasma concentration (Cmax)

  Up to 105 days post dosing

• Time of maximum plasma concentration (Tmax)

  Up to 105 days post dosing

• Terminal half-life (T1/2)

  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)

  Up to 105 days post dosing

• Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)

  Up to 105 days post dosing

Other Outcomes (2)

• Tetanus-antibody titer

  Up to 105 days post dosing

• Tetanus-antibody titer

  Up to 105 days post dosing

Study Arms (3)

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)

Drug: TNM002; Drug: 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)

Drug: TNM002; Drug: 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)

Drug: TNM002; Drug: Placebo

Interventions

TNM002 DRUG

TNM002, intramuscular injection

Cohort 1: TNM002 35 μg/kg or placebo; Cohort 2: TNM002 100 μg/kg or placebo; Cohort 3：TNM002 250 μg/kg or placebo

Placebo DRUG

Placebo, intramuscular injection

Cohort 1: TNM002 35 μg/kg or placebo; Cohort 2: TNM002 100 μg/kg or placebo; Cohort 3：TNM002 250 μg/kg or placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, 18-55 years of age;
• Body mass index (BMI) within 19.0-26.0 kg/m2;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Fifth Affiliated Hospital Sun Yat-sen University

Zhuhai, Guangdong, China

Location

Study Officials

• Zhigang Liu

  The Fifth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 6, 2023
• Study Start: October 15, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Academics who provide a methodologically sound proposal.

Locations

CN (1)