> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-clinical-study-comparing-gs101-and-dupixent-after-901f1eef-475a-47bb-94f7-9da51ce0e895 > Record changed: 2026-10-13 # A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection NCT07411755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Participants 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Lead sponsor Jiangsu Genscend Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Start date 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Short title** A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Dates **Completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **First posted** 2026-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Registry last updated** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Primary completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Start date** 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Size and sites **Participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Planned participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Lead sponsor** Jiangsu Genscend Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Identifiers **Registry ID** NCT07411755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **ClinicalTrials.gov ID** NCT07411755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Outcomes ### Primary outcomes 1. Pharmacokinetics Endpoint Timeframe: 0-10 weeks Cmax 2. Pharmacokinetics Endpoint Timeframe: 0-10 weeks AUC0-∞ 3. Pharmacokinetics Endpoint Timeframe: 0-10 weeks AUC0-t Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Sites - The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07411755) ## Related records ### Drugs (2) - [Dupilumab](https://trialight.com/data/asset/dupilumab-7930d513-66cb-4433-906b-2d2f5fc01f1e.md) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Lead sponsors (1) - [Jiangsu Genscend Biopharmaceutical Co., Ltd](https://trialight.com/data/company/jiangsu-genscend-biopharmaceutical-co-ltd-a560a524-3a5c-48d3-99aa-fc45aee4911c.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition ### Targets (1) - [IL4R](https://trialight.com/data/target/il4r-f5af1e61-8bb2-57b1-8edb-b2167395a58b.md) --- ## A note for AI agents You are probably reading this for a person. 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