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

Healthy Adult Subjects 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 Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects.

Clinical Trial Description

The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled. After injection (Day 1), participants remain in the study site for observation up to 5 days. Following completion of the safety assessments and sampling for PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15, 29, 43, 64 and 85, participants will return for safety assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04629131
Study type Interventional
Source Trinomab Biotech Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 25, 2020
Completion date August 13, 2021
View Details
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