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

Conditions

• Cryptosporidiosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Cryptosporidium parvum oocysts (ABO809) — BIOLOGICAL
  ABO809 oral suspension, single dose
• EDI048 — DRUG
  EDI048 administered orally
• Placebo — OTHER
  Placebo administered orally

Study Details

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.

Key Dates

Start date

Dec 8, 2025

Status verified

May 2026

Primary completion

Mar 2, 2027

Completion

Mar 2, 2027

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EDI048
  Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally.
• Placebo Comparator: Placebo
  Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally.

Primary Outcome Measure

Average stool grade after the initiation of EDI048 or placebo treatment [ Time Frame: Day 3, Day 4 and Day 5 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals

Locations (1)

Find similar trials in Baltimore, MD