Phase 1 GS101 injection versus U.S. and China Dupixent in healthy adults
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
This trial tests whether GS101 produces similar blood levels, safety, and immune responses as the U.S. and China versions of Dupixent in healthy adult men in China.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Male |
| Sponsor | Jiangsu Genscend Biopharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT07411755 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, three-arm, parallel-group study compares the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection with U.S. commercial Dupixent and China commercial Dupixent. A total of 294 healthy male adults are randomized 1:1:1, with 98 participants per treatment group. Participants must meet strict health, BMI, and laboratory criteria and agree to contraception requirements. The primary outcomes are PK similarity and characterization of safety and immune response after dosing.
Who should consider this trial
Good fit: Ideal candidates are healthy adult men who meet the specified BMI and weight ranges, have no significant medical history or abnormal screening tests, and agree to contraception requirements.
Not a fit: People with active medical conditions, a history of multiple allergies, or other disqualifying health issues would not be eligible and would not benefit from this phase 1 PK comparison.
Why it matters
Potential benefit: If GS101 is shown to be similar to Dupixent, it could broaden access and provide an additional treatment option for patients who need dupilumab therapy.
How similar studies have performed: PK and immunogenicity comparisons are a common step for biosimilars and similar monoclonal antibody biosimilars have successfully matched reference products in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suzhou, Jiangsu
- The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Sinian Li, Master
- Email: lisinian@jxingbio.com
- Phone: +086-15800767550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.