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
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).
Interventions
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
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]