A Phase 1, First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes in 12-lead ECGs
研究概览
简要总结
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- •Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- •Participant must have body weight > 45 kg at the Screening Visit.
- •Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m^2 at the Screening Visit. BMI = body weight (kg)/(height [m])^2.
排除标准
- •Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection.
- •Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit.
- •Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study.
- •Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
ME3241
干预措施: ME3241 (Biological)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Changes in 12-lead ECGs
时间窗: From baseline to 12 weeks after the last administration
Evaluation of PR, QRSd, and QT/QTcF intervals
Incidence and severity of AEs and SAEs
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with AEs, treatment-emergent adverse events (TEAEs), and the number of TEAEs
Changes in vital signs
时间窗: From baseline to 12 weeks after the last administration
Evaluation of body temperature, blood pressure, and pulse
Changes in physical examinations
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with normal/non-clinically significant abnormal or clinically significant abnormal results in physical examination
Changes in laboratory parameters
时间窗: From baseline to 12 weeks after the last administration
Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters
Maximum observed serum concentration (Cmax)
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the maximum observed serum concentration of ME3241
Area under the curve from time zero to the last quantifiable concentration (AUClast)
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero to the last quantifiable concentration
Area under the curve from time zero extrapolated to infinity (AUC0-∞)
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero extrapolated to infinity
Area under the curve over the dosing interval after multiple dose administration (AUCtau)
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve over the dosing interval after multiple dose administration
Apparent terminal elimination half-life (t1/2)
时间窗: From baseline to 12 weeks after the last administration
Evaluation of the apparent terminal elimination half-life
次要结局
未报告次要终点