NCT05842798

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	TNM002	TNM002, intramuscular injection
DRUG	Placebo	Placebo, intramuscular injection

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study