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Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
Sponsor: Novartis Pharmaceuticals
Summary
This study has the purpose to demonstrate prospect of benefit of EDI048 on clinical signs and symptoms of cryptosporidiosis to facilitate trial in target population, pediatric patients. This study aims to investigate the efficacy of a new chemical entity, EDI048, in a controlled human infection model of cryptosporidiosis induced by administration of ABO809 in healthy adults, who become symptomatic with disease thereby demonstrating a prospect of benefit for use of EDI048 in children afflicted with cryptosporidiosis.
Official title: A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Assess the Efficacy and Safety and Tolerability of EDI048 in a Cryptosporidium Controlled Human Infection Model (CHIM) in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-12-08
Completion Date
2027-03-02
Last Updated
2026-03-23
Healthy Volunteers
Yes
Conditions
Interventions
Cryptosporidium parvum oocysts (ABO809)
ABO809 oral suspension, single dose
EDI048
EDI048 administered orally
Placebo
Placebo administered orally
Locations (1)
Pharmaron Inc
Baltimore, Maryland, United States