CompletedPhase 1

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

China96 participantsStarted 2026-01-04

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male subjects aged ≥ 18 and ≤ 45 years; * Body mass index (BMI): 19-28 kg/m2 (inclusive), weight 50-90 kg (inclusive), with BMI calculated as: BMI = weight (kg) / height2 (m2); * Results of physical examination, vital signs, laboratory tests, 12-lead ECG, chest X-ray (posteroanterior view), and abdominal B-scan ultrasound are normal or clinically insignificant if abnormal; * Fully understand the purpose and requirements of this study, voluntarily participate in the clinical study and sign the written informed consent form (ICF), and are able to complete the entire study process as required. Exclusion Criteria: * (Screening/Admission interview) Known history of allergy to the investigational product, any of its components, or related products; or a history of allergic diseases such as asthma; or allergic diathesis (e.g., known allergy to two or more substances); * (Screening/Admission interview) A definite history of diseases of the central nervous, cardiovascular, digestive, respiratory, urinary, or hematological systems, or metabolic disorders, or potential underlying diseases that are judged by the investigator to be clinically significant; or other diseases that the investigator considers unsuitable for participation in a clinical study (e.g., history of mental illness); * (Screening/Admission interview) History of severe infection, severe trauma, or major surgery within 6 months prior to screening; * (Screening/Admission interview) History of bloo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary PK endpoint: Cmax

Timeframe: 10 days after dosing

Primary PK endpoint: AUC0-inf

Timeframe: 10 days after dosing

Trial details

NCT IDNCT07300436

SponsorTJ Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-16

View on ClinicalTrials.gov More Healthy Adult Males in China trials