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 — CAUSALITY  

Obesity Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 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). ;

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity
• Overweight

• NCT number: NCT04663139
• Study type: Interventional
• Source: YSOPIA Bioscience
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2020
• Completion date: June 26, 2021