MedTrace Logo

A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)

NCT04891965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-10-17

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.

Conditions

  • Clostridium Difficile Infection Recurrence

Interventions

BIOLOGICAL

ART24

Each ART24 capsule will contain lyophilized ART24 and inactive excipients. ART24 will be supplied in a dose strength of 5×10\^9 CFU/capsule. Subjects will receive 1 capsule daily.

DRUG

Placebo

Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients. Subjects will receive 1 capsule daily.

Sponsors & Collaborators

  • Adiso Therapeutics

    lead INDUSTRY

Principal Investigators

  • Renu Gupta, MD · Adiso Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2022-07-07
Completion
2022-10-13
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT04891965 on ClinicalTrials.gov