Actively Recruiting
A Randomized, Double-blind, Parallel, Single-dose Phase 1 Study Comparing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent4 After Subcutaneous Injection
Led by Jiangsu Genscend Biopharmaceutical Co., Ltd · Updated on 2026-05-20
294
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, three-arm, parallel-group Phase 1 study to compare the pharmacokinetics, safety, and immune response of GS101 injection with two versions of Dupixent4 (U.S. commercial and China commercial) in healthy adult male participants in China. The study involves 294 healthy men aged 18 to 55 years, divided equally among the three treatment groups. This trial aims to demonstrate the similarity between GS101 and the established Dupixent4 treatments. Participants receive a single subcutaneous injection of 300 mg (2.0 mL) of either GS101, U.S. commercial Dupixent4, or China commercial Dupixent4. The injection is administered 5 cm to the left of the umbilicus under fasting conditions. The study is designed to maintain blinding and randomization with three parallel treatment arms. During the 10-week study period, researchers will monitor pharmacokinetics as the primary outcome to assess how the drugs behave in the body. Safety, tolerability, and immune responses will also be evaluated through clinical exams, vital signs, lab tests, ECGs, and chest X-rays. Participants and their partners will use contraceptive methods throughout the study and for three months afterward. The study duration and procedures aim to thoroughly assess the comparability of GS101 to Dupixent4 in healthy male adults.
CONDITIONS
Brief Title
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 55 years
- No significant abnormalities in physical exams, vital signs, chest X-ray, ECG, or lab tests before treatment
- Body mass index (BMI) between 19 and 26 kg/m²
- Body weight between 55 and 85 kg
- Participants and partners agree to use medically accepted contraception from consent signing until three months after dosing
- Participants have no plans to donate sperm and their partners have no plans for pregnancy
You will not qualify if you...
- History or presence of neurological, psychiatric, respiratory, cardiovascular, gastrointestinal, blood, endocrine, musculoskeletal, or other diseases that may interfere with study assessments
- History of two or more drug or food allergies, or specific allergic diseases such as asthma, urticaria, or eczematous dermatitis
- Known hypersensitivity to monoclonal antibodies targeting the same pathway or to any components of the study drug
- Positive results for infectious disease screenings including HIV, hepatitis B, hepatitis C, or syphilis antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 weeks
Participants receive a single subcutaneous injection of either GS101 or Dupixent® under fasting conditions and are monitored for pharmacokinetics, safety, and tolerability.
Multiple visits over 10 weeks for pharmacokinetics and safety assessments
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
Research Team
S
Sinian Li, Master
T
Tao Sun, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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