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

Phase 1, Randomized, Placebo-Controlled, Blinded Study in Healthy Adults Challenged With Enterotoxigenic Escherichia Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mark Klempner · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 or placebo and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. The occurrence of local and systemic reactogenicity (solicited AEs) over the subsequent 7-days post-dosing will be collected; non-solicited non-serious AEs will be collected through 28-days post-dosing and serious adverse events (SAEs) will be collected through 2 months. An independent Safety Monitoring Committee (SMC) will review the cumulative 7-day safety data for the sentinel group and must approve for the study to proceed to Part B. Part B will consist of a single inpatient cohort of up to 34 subjects who will be randomized 1:1 to receive VENBETA6890 15 mg/kg, or placebo on Day -1 at approximately 12 h pre-challenge, Day 1 at approximately 1 h pre-challenge, and Day 1 at approximately 12 h post-challenge. All subjects will be challenged with wild-type ETEC strain H10407 and will be closely monitored on the inpatient unit for ETEC diarrheal illness. Subjects will receive the 3-day course of antibiotic therapy starting on Day 6 or earlier dependent on symptoms. Discharge from the inpatient unit is contingent upon the absence of ETEC diarrheal illness, including no diarrhea and no fever, plus two sequential negative stool cultures for ETEC separated by at least 12 hours. An SMC will review the cumulative safety data after data collected during the Day 29 visit of the inpatient challenge cohort has been compiled.

Conditions

• Diarrhea Infectious

Interventions

Type	Name	Description
DRUG	VENBETA6890	Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1.
DRUG	Placebo	Part A Placebo (saline) will be administered at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1.

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2025-03-26
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study