Clinical Trial

Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults

Study acronym: CRYPTONITE
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Enrollment reduced: 96 -> 80 participants 2026-07-21
notable Enrollment increased: 80 -> 96 participants 2026-04-28
Trial Details
NCT Number NCT07249463
Lead Sponsor Novartis Pharmaceuticals
Conditions Cryptosporidiosis
Enrollment 80 participants
Start Date 2025-12-08
Primary Completion 2027-03-02 (estimated)
Study Completion 2027-03-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-20