NCT04737876已完成1 期
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of Orally Administered BX002-A in Healthy Adult Individuals
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BiomX, Inc.
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety and Tolerability: adverse events
研究概览
简要总结
The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.
详细描述
Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages that can be measured in the stool.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18-65 years old
- •Able to understand study procedures and sign informed consent
排除标准
- •Evidence or history of clinically significant underlying conditions
- •Women who are pregnant or nursing, or plan to become pregnant during study, or women of childbearing potential not using adequate contraceptive measures
- •History of constipation, severe diarrhea and/or loose stools within 14 days
- •History of procedures aimed at modifying the gastrointestinal microbiota within past year (e.g., fecal microbiota transplantation)
- •Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior or planned during study
- •Use of bowel cleansing or preparation in the 4 weeks prior or planned during study
- •Participation in another investigational trial within 30 days
- •Known allergy or hypersensitivity to an excipient in the study drug or placebo
- •Any other reason which according to investigator may impact proper study conduct
- •History of alcohol abuse; drug or medication abuse or tobacco use
- •Subject who cannot be contacted in case of emergency
结局指标
主要结局
Safety and Tolerability: adverse events
时间窗: Through study completion Day 31 (+ 2 days)
Evaluated by reviewing adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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