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.
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).
Cryptosporidium Infection, Cryptosporidiosis
Apr 07, 2022
Nov 29, 2022
18 Years - 50 Years (Adult)
Cryptosporidium parvum oocysts (ABO809)
ABO809 3x10^6 CE/3mL concentrate for oral suspension, single dose at Day 1
Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
Ability to communicate well with the Investigator
- 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.