A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GS101 injection, U.S. commercial Dupixent®, CN commercial Dupixent®.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis (AD). Basic parameters: 18 years — 55 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Parallel, Single-dose, Phase 1 Clinical Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent® After Subcutaneous Injection
Overview
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.
Interventions
- Drug GS101 injection
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions - Drug U.S. commercial Dupixent®
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions - Drug CN commercial Dupixent®
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
Primary outcome measures
- Pharmacokinetics Endpoint [Time frame: 0-10 weeks]
- Pharmacokinetics Endpoint [Time frame: 0-10 weeks]
- Pharmacokinetics Endpoint [Time frame: 0-10 weeks]
Eligibility criteria
Inclusion criteria
- No clinically significant abnormalities detected in physical examination, vital signs, chest X-ray (posteroanterior \[PA\] view), 12-lead ECG, or laboratory tests prior to investigational product administration.
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive) and body weight between 55 and 85 kg (inclusive).
- Participants and their partner agree to use medically accepted contraceptive methods from the signing of the informed consent form until three months after dosing of the investigational product. In addition, participants have no plans to donate sperm, and their partner has no plans for pregnancy.
Exclusion criteria
- History or presence at screening of neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic/lymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments.
- History of drug or food allergy (≥2 types) or history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known hypersensitivity to monoclonal antibodies targeting the same pathway or to investigational product components.
- Positive result for any infectious disease screening, including human immunodeficiency virus (HIV) antibody and p24 antigen, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) IgG antibody, or Treponema pallidum (syphilis) antibody.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07411755 · GS101-01