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

NCT07300436 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-01-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TJ Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-04
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300436 on ClinicalTrials.gov