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
Completed · Phase 1 · Has a placebo group
Conditions studied: Obesity, Metabolic Disease
In brief
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.
Key facts
- Study ID
- NCT04663139
- Run by
- YSOPIA Bioscience
- People needed
- 38
- Starts
- 2020-11-01
- Expected to finish
- 2021-06-26
- Last updated by the study team
- 2021-07-13
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Celerion — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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