Study of Efficacy and Safety of ABO809 in Healthy Participants

An Open Label Cryptosporidium Controlled Human Infection Model (CHIM) to Assess the Efficacy and Safety of ABO809 in Healthy Participants

ClinicalTrials.gov Identifier: NCT05036668

Novartis Reference Number: CABO809A02101

Last Update: Apr 26, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this Phase I controlled human infection model (CHIM) study is to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers results in a Cryptosporidium infection and diarrheal illness. The study will measure fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).

Condition 
Cryptosporidium Infection, Cryptosporidiosis
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Apr 07, 2022
Completion date 
Nov 29, 2022
Gender 
All
Age(s)
18 Years - 50 Years (Adult)

Interventions

Biological
Cryptosporidium parvum oocysts (ABO809)
ABO809 3x10^6 CE/3mL concentrate for oral suspension, single dose at Day 1

Eligibility Criteria

Inclusion Criteria:

Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
Good health
Ability to communicate well with the Investigator

Exclusion Criteria:

- History of Cryptosporidium infection, gastrointestinal conditions (including diarrheal syndromes, gastroenteritis and gastrointestinal tract surgery), immunodeficiency, infections, significant medical concerns, hypersensitivity to nitazoxanide or other specified antibiotics.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Baltimore, 21201
Maryland
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]