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RECRUITING
NCT07249463
PHASE2

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

Sponsor: Novartis Pharmaceuticals

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.

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

Interventions

BIOLOGICAL

Cryptosporidium parvum oocysts (ABO809)

ABO809 oral suspension, single dose

DRUG

EDI048

EDI048 administered orally

OTHER

Placebo

Placebo administered orally

Locations (1)

Pharmaron Inc

Baltimore, Maryland, United States