A Phase I Study of 9MW4113 Injection Versus Dupixent®
- 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®.
- Short title
- A Phase I Study of 9MW4113 Injection Versus Dupixent®
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-08-17
- First posted
- 2026-08-27
- Registry last updated
- 2026-08-27
- Primary completion date
- 2026-07-27
- Start date
- 2026-04-22
- Actual participants
- Participants
- Participant count basis
- Actual
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07791342
- ClinicalTrials.gov ID
- NCT07791342
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Maximum Concentration (Cmax)
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Area under the concentration-time curve time 0 to infinity (AUC0-∞)
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Time of maximum concentration (Tmax)
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Terminal elimination rate constant (λz)
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Terminal elimination half-life (t1/2z), t1/2z = ln2/λz
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Percentage of extrapolated area (AUC\_%Extrap), AUC\_%Extrap = \[(AUC0-∞-AUC0-t)/AUC0-∞\]×100%
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Apparent clearance (CL/F), CL/F=Dose/AUC0-∞
Pharmacokinetics Endpoint
Timeframe: 0-9weeks
Apparent volume of distribution (Vd/F) , Vd/F = (CL/F)/λz
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
Incidence of anti-drug antibodies (ADA)
Timeframe: 0-9weeks
Titer of anti-drug antibodies (ADA)
Timeframe: 0-9weeks
Incidence of neutralizing antibodies (NAb)
Timeframe: 0-9weeks
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- Yes
- 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.
- Chinese healthy participants aged 18 to 50 years, inclusive.
- Body weight between 55 and 85kg, inclusive, body mass index between 19.0 and 28.0kg/m2, inclusive.
- Normal vital signs, physical examination, clinical laboratory test results, and other ancillary examination findings, or abnormalities considered not clinically significant by the investigator.
- 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.
- Participants able to communicate well with the investigator and able to understand and comply with all study requirements.
- Participants with a history of specific allergies or with allergic diathesis (e.g., allergy to two or more drugs or foods).
- Known hypersensitivity to any component of the investigational product or to other similar biological products, especially monoclonal antibodies.
- Presence of active tuberculosis infection as revealed by chest X-ray at screening.
- ≥ 5% change (increase or decrease) in body weight at Day -1 (pre-randomization) versus screening.
- History of chronic or significant diseases involving the cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, psychiatric/neurological, or skeletal systems.
- Prior treatment with a monoclonal antibody targeting the same target, or prior participation in a dupilumab clinical trial.
- Use of biological products within 3 months or 5 half-lives (whichever is longer) prior to screening.
- Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)Wuhan, China