VENBETA6890 for Diarrhea

(MBL-ETEC-21-01 Trial)

Overseen By Sponsor Investigator, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mark Klempner

Trial Summary

What is the purpose of this trial?

This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of VENBETA6890, an orally administered, human monoclonal IgA.

Research Team

Sponsor Investigator, MD

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

This trial is for healthy adults aged 18-45 who can participate in a study where they will be exposed to E. coli bacteria to test a new treatment. People with certain health conditions or on conflicting medications are likely excluded, but specific criteria aren't provided.

Inclusion Criteria

I am between 18 and 45 years old.

Provide written informed consent before initiation of any study procedures

Willing and able to complete all study requirements, restrictions, confinement to the Research Isolation ward, visits and procedures

Exclusion Criteria

Another investigational medication within 60 days or 5 half-lives, whichever is longer prior to Day 1

Consumption of caffeine-containing substances within 72 h prior to Day 1 or Check-in

Occupation involving the handling of ETEC, cholera, or Shigella bacteria

Treatment Details

Interventions

• VENBETA6890 (Monoclonal Antibodies)

Trial Overview The trial is testing VENBETA6890, an oral human monoclonal IgA antibody, against a placebo to see if it's safe and can prevent diarrhea when challenged with E. coli bacteria. Up to 36 participants will be randomly assigned to receive either the drug or placebo.

Participant Groups

Group I: Prt B Arm 1 Experimental Treatment 1 Intervention

Part B Arm 1 Participants receive Investigational Product

Group II: Part A arm 1 Experimental Treatment 1 Intervention

Arm 1 Participant receives Investigational product

Group III: Part A Arm 2 Placebo Group 1 Intervention

Part A Arm 2 participant receives placebo

Group IV: Part B Arm 2 Placebo Group 1 Intervention

Part B Arm 2 Particpants receive placebo

Who Is Running the Clinical Trial?

Mark Klempner

Lead Sponsor

Trials

1

Recruited

40+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Pharmaron CPC, Inc.

Collaborator

Trials

1

Recruited

40+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+