A Phase 1, Open-label, Randomized, 2-part Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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
- None
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
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
- •A total body weight of more than (>) 50 kg
排除标准
- •History of febrile illness that has not fully resolved within 14 days before the dose of study drug.
- •Immunization with a live vaccine within 45 days before study drug administration or a non live vaccine within 14 days before study drug administration.
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A1: Povetacicept Bioavailability
Participants will be randomized to receive one of the two Povetacicept formulations.
干预措施: Povetacicept (Drug)
Part A2: Povetacicept Bioavailability
Participants will be randomized to receive one of the two Povetacicept formulations.
干预措施: Povetacicept (Drug)
Part B1: Povetacicept Bioequivalence
Participants will be randomized to receive one of the two Povetacicept presentations.
干预措施: Povetacicept (Drug)
Part B2: Povetacicept Bioequivalence
Participants will be randomized to receive one of the two Povetacicept presentations.
干预措施: Povetacicept (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
时间窗: From Day 1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept
时间窗: From Day 1 up to Day 30
次要结局
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 31)