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

Phase 1

Completed

• Conditions: Obesity; Metabolic Disease
• Interventions: Drug: Xla1; Drug: Placebo

• Registration Number: NCT04663139
• Lead Sponsor: YSOPIA Bioscience

Brief 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).

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Primary Completion: 2021-06-26
• Study Completion: 2021-06-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
overweight and class 1 obese adult patients receiving Xla1	Xla1	one capsule Xla1 given once daily
overweight and class 1 obese adult patients receiving placebo	Placebo	one capsule placebo given once daily
normal weight healthy adult volunteers receiving Xla1	Xla1	one capsule Xla1 given once daily

Primary Outcome Measures

Name	Time	Method
number of patients experiencing adverse events	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 \[part 2\].

Secondary Outcome Measures

Name	Time	Method
Modulation of the gut microbiota composition	12 weeks	To evaluate the effects of Xla1 on subject's intestinal microbiome ecology
Quantification of Xla1 presence in stools during the study	12 weeks	To evaluate the engraftment of Xla1 in the gastrointestinal tract (GIT)

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States