A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject
研究概览
简要总结
In this clinical trial we will test a new approach for decolonization of S. aureus.
As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
Verum
Low Dose single application Low Dose multiple application High Dose single application high dose multiple application
干预措施: HY_133 (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject
时间窗: baseline, pre-intervention/procedure/surgery, up to Day15
The primary objective of this trial is to evaluate the safety of the HY-133. Fort the primary objective the nature, frequency, and severity of AEs and/or SAEs occurring in the study are recorded as follows: ADRs/AEs/SAEs occurring from the time of application until the final study visit (D15) for each subject A DLT is defined as any AE of Grade 4 or above related to the IMP
次要结局
未报告次要终点