NCT07300436

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

A Randomized, Open-label, Single-dose, Crossover Bioequivalence Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Males in China

Interventions

Type	Name	Description
DRUG	TJ101 injection Test Product	1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per cycle
DRUG	TJ101 injection Reference Product	1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per period

Timeline

• Start date: 2026-01-04
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-12-23
• Last updated: 2026-01-30

Locations

1 site across 1 country: China