Randomised, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity Against Influenza Infection, Safety, Tolerability, and Pharmacokinetics of CC-42344 Via a Human Viral Challenge Model in Healthy Participants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus
研究概览
简要总结
Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured.
详细描述
This is a single-center, phase 2a, randomized, double-blind, placebo-controlled study in healthy adult participants. The primary goal of this study is to assess the antiviral activity of orally administered CC-42344 in an influenza human viral challenge model, and to explore the impact of different dose levels on efficacy. In addition, the safety, tolerability, and pharmacokinetics will be assessed.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Body weight ≥50 kg
- •Body mass index ≥18 kg/m2 and ≤35 kg/m2
- •Serology results consistent with susceptibility to challenge virus infection
排除标准
- •History of or current significant medical condition
- •Upper or lower respiratory tract infection within 4 weeks
- •Vaccination within 4 weeks
研究组 & 干预措施
CC-42344 Dose 1
Low dose group
干预措施: CC-42344 (Drug)
CC-42344 Dose 2
High dose group
干预措施: CC-42344 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus
时间窗: Day 1 to Day 8
Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples
次要结局
- Maximum viral load(Day 1 to Day 8)
- Time to first confirmed nonquantifiable viral assessment(Day 1 to Day 8)
- VL-AUC of influenza challenge virus(Day 1 to Day 8)
- Area under the curve over time of total clinical symptoms score (TSS-AUC)(Day 1 to Day 8)
- Peak TSS(Day 1 to Day 8)
- Peak daily symptom score(Day 1 to Day 8)
- Time to symptom resolution(Day 1 to Day 8)
- Incidence of adverse events (AEs)(Day 1 to Day 28)
- Incidence of serious adverse events (SAEs)(Day 1 to Day 28)
- Incidence of AEs related to viral challenge(Day 1 to Day 28)
- Incidence of SAEs related to viral challenge(Day 1 to Day 28)