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A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects

Healthy Male Subjects Clinical Trial

Official title:
A Randomized, Open-label, Parallel-Group, Comparative Study in Chinese Healthy Male Subjects to Evaluate the Safety and Pharmacokinetic Profile of TG103 Injection Produced by Two Different Manufacturing Processes

Clinical Trial Summary

This study is designed to evaluate the comparability of TG103 injection subject to changes in the manufacturing process in Chinese healthy male subjects.

Clinical Trial Description

This is a randomized, open-label, parallel-group, comparative study to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, safety, and immunogenicity of TG103 injection produced by two different manufacturing processes in Chinese healthy male subjects. Approximately 24 eligible subjects will be randomized in a 1:1 ratio to receive a single dose of TG103 produced by the modified manufacturing process or TG103 produced by the original manufacturing process via subcutaneous (SC) injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04839744
Study type Interventional
Source CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 18, 2021
Completion date July 2, 2021
View Details
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