A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
NCT07411755
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Jiangsu Genscend Biopharmaceutical Co., Ltd
Start date
2026-03-05
Number of sites
- Summary
- 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.
- Short title
- A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-09-01
- First posted
- 2026-02-17
- Registry last updated
- 2026-05-20
- Primary completion date
- 2026-09-01
- Start date
- 2026-03-05
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu Genscend Biopharmaceutical Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07411755
- ClinicalTrials.gov ID
- NCT07411755
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Pharmacokinetics Endpoint
Timeframe: 0-10 weeks
Cmax
Pharmacokinetics Endpoint
Timeframe: 0-10 weeks
AUC0-∞
Pharmacokinetics Endpoint
Timeframe: 0-10 weeks
AUC0-t
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaRecruiting
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Atopic eczema Primary condition