NCT05352269

Safety and Tolerability of FMT Capsules in Healthy Volunteers

Safety and Tolerability of Xbiome Gut Microbial Capsule XBI-302 in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shenzhen Xbiome Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers. The hypothesis of this study is that XBI-302 is safe and well tolerated with the proposed dosing regimens.

Conditions

• Acute-graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	XBI-302	Fecal Microbiota Transplantation Capsules
BIOLOGICAL	XBI-302 Placebo	XBI-302 Placebo

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2022-04-28
• Last updated: 2022-05-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study