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
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metabolic Disease
- Obesity
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is designed as a First in Human, Phase I, clinical trial evaluating safety, tolerability and the impact on the gut microbiota of Xla1. The study will be performed in 2 parts: Part 1: An open label phase in normal weight healthy adult volunteers receiving Xla1. Part 2: A randomized, parallel, double-blind, placebo-controlled phase I in overweight and class 1 obese adult patients receiving either Xla1 or placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 65 years
- Gender
- Both males and females
Description
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...
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).
Tracking Information
- NCT #
- NCT04663139
- Collaborators
- Not Provided
- Investigators
- Not Provided
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