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Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

NCT03824795 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-04-15

No results posted yet for this study

Summary

The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

MGB-BP-3

MGB-BP-3

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • MGB Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Miroslav Ravic, MD · MGB Biopharma Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-04-03
Completion
2020-04-03
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT03824795 on ClinicalTrials.gov