Actively Recruiting
A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
Led by TJ Biopharma Co., Ltd. · Updated on 2026-01-30
96
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 60#8805; 18 and 60#8804; 45 years
- Body mass index (BMI) between 19 and 28 kg/m2 inclusive
- Weight between 50 and 90 kg inclusive
- Normal or clinically insignificant results in physical exam, vital signs, lab tests, ECG, chest X-ray, and abdominal ultrasound
- Able to understand study purpose, voluntarily consent, and complete the study
You will not qualify if you...
- Allergy to the investigational product, its components, or related products or history of allergic diseases such as asthma
- History of significant diseases of central nervous, cardiovascular, digestive, respiratory, urinary, hematological systems, metabolic disorders, or other conditions unsuitable for participation
- Severe infection, trauma, or major surgery within 6 months prior to screening
- Blood donation, blood loss 60#8805; 400 mL, or blood transfusion within 3 months prior to screening, or planned blood donation within 3 months after study
- Positive tests for HIV, hepatitis B, hepatitis C, syphilis, or Treponema pallidum
- Participation in any clinical trial involving drugs, vaccines, or medical devices within 3 months before dosing or still in follow-up
- Use of prescription drugs affecting liver enzymes within 4 weeks before dosing or use of over-the-counter drugs or supplements within 2 weeks before dosing
- Prior use of growth hormone drugs
- Positive anti-TJ101 anti-drug antibody at screening
- History of drug abuse
- Smoking 5 or more cigarettes per day within 3 months prior or inability to stop tobacco use during study
- Alcohol use exceeding 14 units weekly within 3 months prior or unwillingness to stop during study
- Positive alcohol breath or urine drug test at admission
- Difficulty or phobia with venipuncture or intravenous procedures
- Plans for procreation or sperm donation from first dose until 3 months after last dose without reliable contraception
- Abdominal conditions interfering with injection or local reaction observation
- Other conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
B
Biwei Zeng
CONTACT
L
Liting Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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