Study of Efficacy and Safety of ABO809 in Healthy Participants

Completed · Phase 1

Conditions studied: Cryptosporidium Infection, Cryptosporidiosis

In brief

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).

Key facts

Study ID

NCT05036668

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2022-04-07

Expected to finish

2022-12-27

Last updated by the study team

2024-10-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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