drugset / Trial / NCT07300436
A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TJ101 | Protein / enzyme biologic | 1.2 mg/kg | Subcutaneous |
Indications
No indication recorded.