PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
详细描述
PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.
Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •Body mass index (BMI) 18 to 32 kg/m2, inclusive.
- •Male or female 18 to 50 years of age, inclusive.
- •Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.
排除标准
- •Women who are pregnant or breastfeeding.
- •Evidence of active or chronic infections.
- •Previous exposure to PRV-
- •Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.
研究组 & 干预措施
Cohort A (PRV-3279 or placebo)
Sterile solution for intravenous administration, 3 doses, every 2 weeks
干预措施: PRV-3279 or placebo (Biological)
Cohort B (PRV-3279 or placebo)
Sterile solution for intravenous administration, 3 doses, every 2 weeks
干预措施: PRV-3279 or placebo (Biological)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: 85 days
Assessment of safety and tolerability
次要结局
未报告次要终点