Healthy Participants
Conditions
Brief 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®.
Interventions
BIOLOGICAL9MW4113 injection
"9MW4113 injection; 300mg/2.0mL; subcutaneous injection.
BIOLOGICALDupilumab
"Dupixent®; 300mg/2.0mL; subcutaneous injection.
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Endpoint | 0-9weeks | Maximum Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Endpoint | 0-9weeks | Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) |
| Safety Assessments | 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) | 0-9weeks | — |
| Titer of anti-drug antibodies (ADA) | 0-9weeks | — |
| Incidence of neutralizing antibodies (NAb) | 0-9weeks | — |
Countries
China
Outcome results
None listed