Study S003292

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

ClinicalTrials.gov record

Registration

Registration: NCT04839744
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 24
Start: 2021-05-18
Primary completion: 2021-06-15
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions: Healthy Male Subjects
Interventions: DRUG:TG103 produced by the modified manufacturing process; DRUG:TG103 produced by the original manufacturing process
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Peak Plasma Concentration (Cmax) [Day1-5, 7,9,10, 15, and 28]
Area under the plasma concentration versus time curve (AUC) [Day1-5, 7,9,10, 15, and 28]

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