A Randomized, Double-blinded, Parallel, Single-dose, PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent® in Healthy Chinese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 198
- 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, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.
详细描述
The study has a screening period of 28 days. PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Chinese healthy subjects aged from 18 to 50 years (including the boundary value)
- •Normal vital signs, physical examinations, ECG, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment;
- •Body weight between 50-90kg and BMI between 19.0-26.0kg/m2 (including boundary value);
排除标准
- •People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
- •People with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components.
- •People who have special dietary requirements or are unable to follow a uniform diet.
- •Dizzy blood, dizzy needle history.
- •Blood donation > 400 ml within 3 months or > 200 ml within 4 weeks prior to screening, or planning to donate blood during the study.
- •Having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration.
研究组 & 干预措施
Dupixent®
Dupixent®; 300mg/2.0mL; subcutaneous injection
干预措施: Dupixent® (Drug)
QL2108 injection
QL2108 injection; 300mg/2.0mL; subcutaneous injection
干预措施: QL2108 injection (Drug)
结局指标
主要结局
Pharmacokinetics Endpoint
时间窗: 0-8weeks
AUC0-∞
次要结局
未报告次要终点