Recruiting
Phase 2

EDI048

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07249463

Conditions

Cryptosporidiosis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Cryptosporidium parvum oocysts (ABO809)

EDI048

Placebo

Study Details

Brief 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.

Conditions

Cryptosporidiosis

Study ID

NCT07249463

Start date

Dec 8, 2025

Status verified date

Aug, 2026

Completion date

Mar 23, 2027

Anticipated

Primary completion date

Mar 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Ability to communicate well with the Investigator, and to understand and comply with the requirements of the study.
  • Male and female participants must be between 18 to 50 years of age and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening and Baseline.
  • Demonstrate thorough understanding of cryptosporidiosis and measures to prevent secondary spread via education provided at screening.
  • Must have a body mass index (BMI) within the range of 18-32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
  • Have not received ABO809 or EDI048 in prior clinical trials.

Exclusion Criteria:

  • History of Cryptosporidium infection.
  • Current (based on screening laboratory tests) or history of infectious diarrhea associated with international travel in the last 12 months or C. difficile infection within 6 months prior to Screening.
  • Employment as a healthcare worker with direct patient care, in a daycare center (e.g., for children or the elderly), or direct food handler (individuals who work directly with food in commercial establishments).
  • Participants who share a home with any of the following:
  • a pregnant woman,
  • a person <4 years old or >65 years old,
  • a person who is infirmed,
  • a person who is immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
  • Residents of dormitories with shared bathrooms would also be excluded.
  • Any significant medical history including, but not limited to, conditions of the cardiac, pulmonary, gastrointestinal, renal, endocrine, reproductive, immune or other systems.
  • Use of investigational drugs within 5 half-lives of the drug or its major metabolites or 30 days of enrollment (Day 1), whichever is longer.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the trial; pregnant or nursing (lactating) women.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cryptosporidium parvum oocysts (ABO809)

ABO809 oral suspension, single dose

EDI048

EDI048 administered orally

Placebo

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 and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Locations

Pharmaron Inc

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Caroline Sarnecki

+1 410 245 6888caroline.sarnecki@pharmaron.com

Principal Investigator:

Charmagne Beckett

Cinn Children Hosp Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229-3039

Contacts

Michelle Dickey

+1 800 344 2462Michelle.Dickey@cchmc.org

Principal Investigator:

Robert Frenck

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Cryptosporidiosis
  • Cryptosporidium
  • EDI048
  • ABO809
  • Controlled human infection model
  • CHIM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.