A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose-Escalation First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK111 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent AE/SAEs
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111 in healthy subjects following SC administration. The study will consist of cohorts of healthy subjects. Cohort 1, four unique subjects will be randomized to receive either active AK111 (N=3) or matching placebo (N=1). Cohorts 2, 3, 4 and 5, eight unique subjects will be randomized to receive either active AK111 (N=6) or matching placebo (N=2). Approximately 36 subjects will be treated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AK111 30mg
Single dose of 30mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
AK111 75mg
Single dose of 75mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
AK111 150mg
Single dose of 150mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
AK111 300mg
Single dose of 300mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
AK111 450mg
Single dose of 450mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
AK111 600mg
Single dose of 600mg AK111 or placebo is administered subcutaneously to healthy subjects
干预措施: AK111 or Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent AE/SAEs
时间窗: From baseline through 12 weeks
次要结局
- Area under the concentration curve (AUC) of AK111(From baseline through 12 weeks)
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [(From baseline through 12 weeks)
- Maximum observed concentration (Cmax) of AK111(From baseline through 12 weeks)
- The endpoint for assessment of PD including the change from baseline in serum IL-17A level and serum cytokines.(From baseline through 12 weeks)