A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- TEAEs following IV dosing
研究概览
简要总结
Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects
详细描述
This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).
Safety assessments will include adverse events (AEs), concomitant medications, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood samples for PK, PD, and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Healthy subjects
- •Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2
排除标准
- •Poor peripheral venous access
- •Clinically-significant illness within 4 weeks of dose administration
- •Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening
研究组 & 干预措施
KPL-404 (IV Administration)
干预措施: KPL-404 (Drug)
KPL-404 (IV Administration)
干预措施: Matching Placebo (Other)
KPL-404 (SC Administration)
干预措施: KPL-404 (Drug)
KPL-404 (SC Administration)
干预措施: Matching Placebo (Other)
结局指标
主要结局
TEAEs following IV dosing
时间窗: Up to 65 days post dose
After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group
TEAEs following SC dosing
时间窗: Up to 65 days post dose
After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group
次要结局
未报告次要终点