NCT04663139

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: YSOPIA Bioscience · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Obesity
• Metabolic Disease

Interventions

Type	Name	Description
DRUG	Xla1	Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta)
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-06-26
• Completion: 2021-06-26
• First posted: 2020-12-10
• Last updated: 2021-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study