Actively Recruiting
A Phase 1 Study of GS101 Injection
Led by Jiangsu Genscend Biopharmaceutical Co., Ltd · Updated on 2026-04-24
294
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.
CONDITIONS
Official Title
A Phase 1 Study of GS101 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No significant abnormalities in physical exam, vital signs, chest X-ray, ECG, or lab tests before dosing
- Body mass index (BMI) between 19 and 26 kg/m8
- Body weight between 55 and 85 kg
- Male participants aged 18 to 55 years
- Participants and partners agree to use medically accepted contraceptives from consent until 3 months after dosing
- No plans to donate sperm or for partner to become pregnant during the study period
You will not qualify if you...
- History or current neurological, psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic, endocrine, musculoskeletal, or other diseases interfering with study
- History of drug or food allergies (two or more types) or specific allergic diseases like asthma, urticaria, eczematous dermatitis
- Known hypersensitivity to monoclonal antibodies targeting the same pathway or to study product components
- Positive screening for infectious diseases including HIV, hepatitis B, hepatitis C, or syphilis
AI-Screening
AI-Powered Screening
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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
CONTACT
T
Tao Sun, Master
CONTACT
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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