At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Cryptosporidium Controlled Human Infection Model (CHIM) to Assess the Efficacy and Safety of ABO809 in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Cryptosporidium parvum oocysts (ABO809) for Cryptosporidium Infection, Cryptosporidiosis. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).
Study Details
Timeline
Interventions
ABO809 3x10\^6 CE/3mL concentrate for oral suspension, single dose at Day 1