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CryptosporidiosisHealthy volunteersBiologicalDrugPhase 2

What this study is

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.

What's being tested

  • Cryptosporidium parvum oocysts (ABO809)

    Intervention · BIOLOGICAL

    ABO809 oral suspension, single dose

  • EDI048

    Intervention · DRUG

    EDI048 administered orally

  • Placebo

    Intervention · OTHER

    Placebo administered orally

Study details

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
Sponsor
Novartis Pharmaceuticals
Conditions
Cryptosporidiosis
Enrolling
80 people
Starts
2025-12-08
Est. completion
2027-03-23
Design
Double-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗