A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
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
- Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
研究概览
简要总结
A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is male, with Fitzpatrick skin types 1 to 3
- •Subject is aged between 18 to 55 years, inclusive
- •Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- •Healthy as determined by a responsible physician, based on medical evaluation
- •Must be willing to use birth control as indicated
排除标准
- •Subject is known to have immune deficiency or is immunocompromised
- •Subject has had a recent acute infection or chronic infection
- •Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug
- •Clinically relevant history of abnormal physical or mental health (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)
研究组 & 干预措施
RIST4721 150mg
RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.
干预措施: RIST4721 (Drug)
RIST4721 300mg
RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.
干预措施: RIST4721 (Drug)
RIST4721 300mg
RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.
干预措施: Placebo (Drug)
RIST4721 150mg
RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
时间窗: Blister formation to Hour 30
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo
时间窗: Blister formation to Hour 24
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo
时间窗: Blister formation to Hour 36
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
次要结局
未报告次要终点