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Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

NCT07285213 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-05-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.

Conditions

  • Clostridioides Difficile Infection

Interventions

OTHER

Placebo

Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.

DRUG

AZD5148

Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-04-20
Completion
2028-01-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT07285213 on ClinicalTrials.gov