A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of ABP-671 in Healthy Volunteers in the United States
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.
详细描述
Primary Objectives:
• To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy Volunteers (HVs).
Secondary Objectives:
• To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single ascending oral doses of ABP-671 in HVs.
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 45 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
ABP-671, Cohort 1-
ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: ABP-671 (Drug)
ABP-671, Cohort 1-
ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: Placebo (Other)
ABP-671, Cohort 2-
ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: ABP-671 (Drug)
ABP-671, Cohort 2-
ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: Placebo (Other)
ABP-671, Cohort 3-
ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: ABP-671 (Drug)
ABP-671, Cohort 3-
ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: Placebo (Other)
ABP-671, Cohort 4-
ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: ABP-671 (Drug)
ABP-671, Cohort 4-
ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: baseline to 7 days
Incidence of adverse events
Maximum tolerable dose
时间窗: baseline to 7 days
Maximum tolerable dose
次要结局
- Peak plasma concentration(baseline to 72 hours)
- half-life(baseline to 72 hours)
- area under the curve(baseline to 72 hours)
- volume of distribution(baseline to 72 hours)
- level of serum and urine uric acid(baseline to 72 hours)
- level of serum and urine creatinine(baseline to 72 hours)