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

NCT07249463 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CEDI048A12201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Average stool grade after the initiation of EDI048 or placebo treatment

  To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.

  Day 3, Day 4 and Day 5

Secondary Outcomes (17)

• Maximum stool grade after the initiation of EDI048 or placebo treatment

  Day 3, Day 4 and Day 5

• Time to resolution of clinical diarrheal illness

  up to Day 35

• Number of participants with associated gastrointestinal symptoms

  up to Day 35

• Number of diarrhea episodes per participant

  up to Day 35

• Overall diarrheal stool weight

  up to Day 35

Study Arms (2)

EDI048

EXPERIMENTAL

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

Biological: Cryptosporidium parvum oocysts (ABO809); Drug: EDI048

Placebo

PLACEBO COMPARATOR

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

Biological: Cryptosporidium parvum oocysts (ABO809); Other: Placebo

Interventions

EDI048 DRUG

EDI048 administered orally

EDI048

Cryptosporidium parvum oocysts (ABO809) BIOLOGICAL

ABO809 oral suspension, single dose

EDI048; Placebo

Placebo OTHER

Placebo administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Pharmaron Inc

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Cryptosporidiosis

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)