A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China

This is Single-center, randomized, open-label, single-dose, two-period crossover study design. The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.

NCT Number	NCT07300436
Lead Sponsor	TJ Biopharma Co., Ltd.
Conditions	Healthy Adult Males in China
Enrollment	96 participants
Start Date	2026-01-04
Primary Completion	2026-03-16 (estimated)
Study Completion	2026-03-16 (estimated)
Updated on ClinicalTrials.gov	2026-06-24