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RECRUITING
NCT07300436
PHASE1

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

Sponsor: TJ Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-01-04

Completion Date

2026-06

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China