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Study of Efficacy and Safety of ABO809 in Healthy Participants

NCT05036668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-02

Study results available
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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).

Conditions

  • Cryptosporidium Infection, Cryptosporidiosis

Interventions

BIOLOGICAL

Cryptosporidium parvum oocysts (ABO809)

ABO809 3x10\^6 CE/3mL concentrate for oral suspension, single dose at Day 1

Sponsors & Collaborators

Principal Investigators

  • Mohamed Al-Ibrahim · Pharmaron CPC, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2022-11-07
Completion
2022-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036668 on ClinicalTrials.gov