NCT04839744

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	TG103 produced by the modified manufacturing process	Drug: TG103 (a modified manufacturing process), 15mg, SC
DRUG	TG103 produced by the original manufacturing process	Drug: TG103 (the original manufacturing process), 15mg, SC

Timeline

• Start date: 2021-05-18
• Primary completion: 2021-06-15
• Completion: 2021-07-02
• First posted: 2021-04-09
• Last updated: 2021-12-22

Locations

1 site across 1 country: China