A Phase I Study of 9MW4113 Injection Versus Dupixent®

Inclusion criteria

• 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.

Exclusion criteria

• 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.