NCT07791342进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Endpoint
研究概览
简要总结
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pharmacokinetics Endpoint
时间窗: 0-9weeks
Maximum Concentration (Cmax)
次要结局
- Titer of anti-drug antibodies (ADA)(0-9weeks)
- Incidence of neutralizing antibodies (NAb)(0-9weeks)
- Pharmacokinetics Endpoint(0-9weeks)
- Safety Assessments(0-9weeks)
- Incidence of anti-drug antibodies (ADA)(0-9weeks)
研究者
研究点 (1)
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