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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 11, 2025

Primary Completion Date

May 22, 2025

Study Completion Date

May 22, 2025

Conditions
Diarrhea Infectious
Interventions
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.

Trial Locations (1)

21201

Pharmaron CPC, Baltimore

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Pharmaron CPC, Inc.

UNKNOWN

collaborator

University of Maryland

OTHER

lead

Mark Klempner

OTHER

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 | Biotech Hunter | Biotech Hunter