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Safety and Tolerability of FMT Capsules in Healthy Volunteers

NCT05352269 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-05-06

No results posted yet for this study

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

BIOLOGICAL

XBI-302

Fecal Microbiota Transplantation Capsules

BIOLOGICAL

XBI-302 Placebo

XBI-302 Placebo

Sponsors & Collaborators

  • Beijing Improve-Quality Tech.Co., Ltd.

    collaborator UNKNOWN

  • Shenzhen Xbiome Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fang Hou, MD · Bejing Goboard Boren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-08-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352269 on ClinicalTrials.gov