drugset / Trial / NCT07300436

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

NCT07300436 ↗

Phase 1 Completed 96 enrolled TJ Biopharma Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2026-01-04
Primary completion
2026-03-16
Completion
2026-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject TJ101 Protein / enzyme biologic 1.2 mg/kg Subcutaneous

Indications

No indication recorded.