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

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.

Description

Eligibility

Age range

18–50 years

Sex

All

Healthy volunteers

Yes

Interventions

• Biological
  Cryptosporidium parvum oocysts (ABO809)

  ABO809 oral suspension, single dose

• Drug
  EDI048

  EDI048 administered orally

• Other
  Placebo

  Placebo administered orally

Location