Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- number of patients experiencing adverse events
研究概览
简要总结
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
详细描述
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
The following objectives will be addressed in the program: 1) the primary objective of the study is to assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part 1], and, subsequently, in overweight and Stage I obese adults [part 2]. 2) the secondary objectives comprise additional evaluation of the effects of Xla1 on subject's intestinal microbiome ecology and evaluation of the engraftment of Xla1 in the gastrointestinal tract (GIT).
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)
盲法说明
The randomization list will be generated by a statistician not involved in the study using randomly permuted blocks and will be stratified by BMI category (overweight or obese) and sex.
入排标准
- 年龄范围
- 19 Years 至 65 Years（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
normal weight healthy adult volunteers receiving Xla1
one capsule Xla1 given once daily
干预措施: Xla1 (Drug)
overweight and class 1 obese adult patients receiving Xla1
one capsule Xla1 given once daily
干预措施: Xla1 (Drug)
overweight and class 1 obese adult patients receiving placebo
one capsule placebo given once daily
干预措施: Placebo (Drug)
结局指标
主要结局
number of patients experiencing adverse events
时间窗: 12 weeks
To assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) \[part 1\], and, subsequently, in overweight and class I obese adults \[part 2\].
次要结局
- Modulation of the gut microbiota composition(12 weeks)
- Quantification of Xla1 presence in stools during the study(12 weeks)