> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-study-of-9mw4113-injection-versus-dupixent-256732f4-6ef7-455a-976e-e8f1c439640c > Record changed: 2026-10-13 # A Phase I Study of 9MW4113 Injection Versus Dupixent® NCT07791342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Participants 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Lead sponsor Mabwell (Shanghai) Bioscience Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Start date 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Title and summary **Summary** It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants. A total of 208 healthy participants are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml 9MW4113 injection or Dupixent®. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Short title** A Phase I Study of 9MW4113 Injection Versus Dupixent® Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Official title** A Randomized, Double-Blind, Parallel Study to Evaluate the Pharmacokinetic, Safety, and Immunogenicity Similarity Between 9MW4113 and Dupixent® Following a Single Subcutaneous Dose in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Dates **Completion date** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **First posted** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Registry last updated** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Primary completion date** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Start date** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Size and sites **Actual participants** 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Participants** 208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Lead sponsor** Mabwell (Shanghai) Bioscience Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Identifiers **Registry ID** NCT07791342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **ClinicalTrials.gov ID** NCT07791342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Outcomes ### Primary outcomes 1. Pharmacokinetics Endpoint Timeframe: 0-9weeks Maximum Concentration (Cmax) 2. Pharmacokinetics Endpoint Timeframe: 0-9weeks Area under the concentration-time curve time 0 to infinity (AUC0-∞) ### Secondary outcomes 1. Pharmacokinetics Endpoint Timeframe: 0-9weeks Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) 2. Pharmacokinetics Endpoint Timeframe: 0-9weeks Time of maximum concentration (Tmax) 3. Pharmacokinetics Endpoint Timeframe: 0-9weeks Terminal elimination rate constant (λz) 4. Pharmacokinetics Endpoint Timeframe: 0-9weeks Terminal elimination half-life (t1/2z), t1/2z = ln2/λz 5. Pharmacokinetics Endpoint Timeframe: 0-9weeks Percentage of extrapolated area (AUC\\\_%Extrap), AUC\\\_%Extrap = \\\[(AUC0-∞-AUC0-t)/AUC0-∞\\\]×100% 6. Pharmacokinetics Endpoint Timeframe: 0-9weeks Apparent clearance (CL/F), CL/F=Dose/AUC0-∞ 7. Pharmacokinetics Endpoint Timeframe: 0-9weeks Apparent volume of distribution (Vd/F) , Vd/F = (CL/F)/λz 8. Safety Assessments Timeframe: 0-9weeks adverse events, concomitant medications, concomitant non-drug therapies, injection site irritation assessment, laboratory tests (complete blood count, blood biochemistry test, urinalysis and coagulation function) clinical symptoms, vital signs , 12 lead ECGs, physical examination 9. Incidence of anti-drug antibodies (ADA) Timeframe: 0-9weeks 10. Titer of anti-drug antibodies (ADA) Timeframe: 0-9weeks 11. Incidence of neutralizing antibodies (NAb) Timeframe: 0-9weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Participants who fully understand the study objectives, nature, methods, and possible adverse reactions, volunteer to participate, and sign the ICF before any study-related procedures begin. 2. Chinese healthy participants aged 18 to 50 years, inclusive. 3. Body weight between 55 and 85kg, inclusive, body mass index between 19.0 and 28.0kg/m2, inclusive. 4. Normal vital signs, physical examination, clinical laboratory test results, and other ancillary examination findings, or abnormalities considered not clinically significant by the investigator. 5. Female participants who are not planning to become pregnant and who agree to use adequate contraception from 2 weeks prior to screening to 6 months after dosing. 6. Participants able to communicate well with the investigator and able to understand and comply with all study requirements. ### Exclusion criteria 1. Participants with a history of specific allergies or with allergic diathesis (e.g., allergy to two or more drugs or foods). 2. Known hypersensitivity to any component of the investigational product or to other similar biological products, especially monoclonal antibodies. 3. Presence of active tuberculosis infection as revealed by chest X-ray at screening. 4. ≥ 5% change (increase or decrease) in body weight at Day -1 (pre-randomization) versus screening. 5. History of chronic or significant diseases involving the cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, psychiatric/neurological, or skeletal systems. 6. Prior treatment with a monoclonal antibody targeting the same target, or prior participation in a dupilumab clinical trial. 7. Use of biological products within 3 months or 5 half-lives (whichever is longer) prior to screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## Sites - Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)Wuhan, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791342) ## 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) - [Mabwell (Shanghai) Bioscience Co., Ltd.](https://trialight.com/data/company/mabwell-shanghai-bioscience-co-ltd-94540514-5802-40a0-b2fa-222ee3c6bfeb.md) ### 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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