VENBETA6890 for Diarrhea

(MBL-ETEC-21-01 Trial)

Overseen By Sponsor Investigator, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Mark Klempner

Must not be taking: Laxatives, Antibiotics, Steroids, others

Disqualifiers: Pregnancy, IgA deficiency, Immunosuppression, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VENBETA6890, to determine if it can safely and effectively reduce diarrhea caused by Enterotoxigenic Escherichia coli (ETEC). Participants will receive either the new treatment or a placebo (a harmless pill with no active ingredients) for comparison. The trial aims to identify any side effects and assess the effectiveness of VENBETA6890. It seeks healthy adults who can stay in a research facility and have not experienced certain stomach issues or infections in recent years. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any prescription and over-the-counter medications, traditional Chinese medicine, herbal medicine, vitamins, minerals, and other dietary supplements at least 14 days before the study and throughout its duration. If you are on any medications that might affect immune function, you must stop them 30 days before the study.

Is there any evidence suggesting that VENBETA6890 is likely to be safe for humans?

Research shows that VENBETA6890 is in the early stages of human testing, so information about its safety is limited. In this Phase 1 trial, the main goal is to ensure the treatment's safety and assess its tolerance in healthy adults. Researchers closely monitor the trial, reporting and reviewing any side effects, whether mild or serious.

Early-stage trials like this aim to identify any immediate health issues caused by the treatment. If the FDA had approved the treatment for other conditions, it might suggest some known safety, but that is not the case here. Therefore, participants must understand that this is the first step in learning about VENBETA6890's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diarrhea, which often include over-the-counter medications like loperamide and bismuth subsalicylate, VENBETA6890 is unique because it introduces a new active ingredient with a different mechanism of action. While traditional treatments primarily aim to slow down gut movement, VENBETA6890 targets specific receptors in the digestive system to potentially offer more targeted relief. Researchers are excited about VENBETA6890 because it could offer quicker symptom relief and improved effectiveness for patients who do not respond well to existing options. This novel approach may lead to a significant advancement in managing diarrhea.

What evidence suggests that VENBETA6890 might be an effective treatment for diarrhea?

Research has shown that VENBETA6890, which participants in this trial may receive, could be a promising treatment for diarrhea caused by Enterotoxigenic Escherichia coli (ETEC). This treatment is an orally administered human-made antibody. Early studies suggest it might help shorten and lessen the severity of diarrhea by directly targeting ETEC in the gut. The treatment aims to prevent the bacteria from adhering to the gut lining, which is how they cause illness. Although detailed human data remains limited, the mechanism and early results are promising for its effectiveness against ETEC-related diarrhea. ^{1 4 6 7 8}

Who Is on the Research Team?

Sponsor Investigator, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

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

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

I agree not to consume live-culture yogurt or probiotics for at least 14 days before starting VENBETA6890 and during the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Sentinel dosing group receives VENBETA6890 or placebo, with monitoring for adverse events

2 days

Multiple visits for dosing and monitoring

Treatment Part B

Inpatient cohort receives VENBETA6890 or placebo, followed by ETEC challenge and monitoring

6 days

Inpatient stay with continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 days

What Are the Treatments Tested in This Trial?

Interventions

• VENBETA6890

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.

How Is the Trial Designed?

Group I: Part B Arm 1 Experimental Treatment 1 Intervention

Part B Arm 1 Participants receive Investigational Product

Group II: Part A arm 1 Investigational Product Experimental Treatment 1 Intervention

Arm 1 Investigational product - Venbeta

Group III: Part A Arm 2 Placebo Group 1 Intervention

Part A Arm 2 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+

Published Research Related to This Trial

The 5-HT3-receptor antagonist KB-R6933 effectively inhibited diarrhea induced by serotonin (5-HT) in mice, suggesting its potential as a treatment for certain types of diarrhea.

KB-R6933 also reduced intestinal fluid secretion stimulated by cholera toxin in rats, indicating its broader therapeutic potential in managing diarrhea-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the 5-hydroxytryptamine3 (5-HT3)-receptor antagonist KB-R6933 on experimental diarrhea models. Ozaki, A., Yoshidomi, M., Sukamoto, T.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06896136/study-in-healthy-adults-challenged-with-enterotoxigenic-e-coli-of-the-safety-tolerability-and-anti-diarrheal-activity-of-venbeta6890-an-orally-administered-human-monoclonal-iga

Study in Healthy Adults Challenged With Enterotoxigenic E ... Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an ...

2. trial.medpath.com trial.medpath.com/clinical-trial/ad2e71aec26d7ad4/nct06896136-venbeta6890-anti-diarrheal-e-coli-study

Study in Healthy Adults Challenged With Enterotoxigenic E ... Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/69/gastroenteritis

Gastroenteritis Clinical Research Trials The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute ...

4. malacards.org malacards.org/card/dysentery

Dysentery Integrated disease information for Dysentery including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 data sources.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32656217/

Randomized, Placebo-Controlled, Double-Blind and Open ... The primary endpoint of the treatment study was met with a decreased time to resolution of diarrhea in SF68-treated patients compared to ...

6. ctv.veeva.com ctv.veeva.com/study/phase-1-randomized-placebo-controlled-blinded-study-in-healthy-adults-challenged-with-enterotoxig

Study in Healthy Adults Challenged With Enterotoxigenic E ... An SMC will review the cumulative safety data after data collected during the Day 29 visit of the inpatient challenge cohort has been compiled.

7. synapse.patsnap.com synapse.patsnap.com/organization/521d0dfe1dd6cada6d3063d7492f2716

Pharmaron CPC, Inc. - Drug pipelines, Patents, Clinical trials RESULTS: Solicited and unsolicited adverse events were reported at similar rates for both formulations. Serious adverse events were reported for six (1.1%) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7326027/

Randomized, Placebo-Controlled, Double-Blind and Open ... The rate of patients with ongoing diarrhea for three or more days was significantly reduced from 59.2 to 50.2%, and median duration of diarrhea ...