CompletedPhase 1

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

United States36 participantsStarted 2025-02-11

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Oral, implantable, transdermal, injectable, or intravaginal hormonal contraception taken for at least 90 days prior to Screening
✓. Intrauterine device (IUD \[copper or hormonal\])
✓. Contraceptive sponge with condom Male subjects must agree not to donate sperm from the time of Check-in through 90 days after the final dose of study drug 9. Agrees to avoid live-culture yogurt and other probiotics for at least 14 days prior to the first dose of VENBETA6890 and during the study.

What they're measuring

Number of Participants who Experience Treatment Emergent Adverse Events

Timeframe: up to day 60

Proportion of Participants who experience treatment emergent adverse events.

Timeframe: up to 60 days

Trial details

NCT IDNCT06896136

SponsorMark Klempner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-22

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