NCT04818398已完成1 期
Single-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-6016a After Subcutaneous Injection in Healthy Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Treatment-emergent Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy male subjects.
- •Age ≥20 and ≤45 years upon providing informed consent.
- •Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening.
排除标准
- •Have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
- •Have alcohol or drug dependence, etc.
研究组 & 干预措施
DS-6016a dose level 2
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
DS-6016a dose level 1
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
DS-6016a dose level 3
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
DS-6016a dose level 4
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
DS-6016a dose level 5
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
DS-6016a dose level 6
Experimental
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
干预措施: DS-6016a (Drug)
Placebo
Placebo Comparator
Participants will be randomized to receive a single, subcutaneous injection of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Reporting Treatment-emergent Adverse Events
时间窗: Day 1 through end of study, up to 8 weeks post-dose
次要结局
- Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)(Day 1 (pre-dose), Day 29 and Day 57 post-dose)
- Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies(Day 1 (pre-dose), Day 29 and Day 57 post-dose)
- Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Pharmacokinetic Parameter of Area Under the Concentration-time Curve of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Pharmacokinetic Parameter of Total Clearance (CL/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Pharmacokinetic Parameter of Terminal elimination half-life (t1/2) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Pharmacokinetic Parameter of Volume of Distribution (Vz/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a(Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57)
- Proportion of Participants Who Have Treatment-emergent ADAs(Day 1 (pre-dose), Day 29 and Day 57 post-dose)
研究者
研究点 (1)
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