EDI048 for relieving cryptosporidiosis symptoms after controlled exposure in healthy adults

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

This trial will test whether EDI048 can reduce diarrhea and other symptoms in healthy adults who are deliberately exposed to Cryptosporidium.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07249463 on ClinicalTrials.gov

What this trial studies

In a placebo-controlled, participant- and investigator-blinded multicenter design, healthy adults are given Cryptosporidium parvum oocysts (ABO809) to induce symptomatic infection. Once participants develop diarrhea and symptoms consistent with cryptosporidiosis, they are randomized 1:1 to receive either EDI048 or placebo. Clinical signs, symptom severity, and safety/tolerability are monitored to determine whether EDI048 shortens or lessens illness. Findings are intended to support further trials in the target pediatric population.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–50 with BMI 18–32 kg/m2, no prior Cryptosporidium infection, able to consent and follow study procedures, and willing to undergo controlled exposure and close monitoring.

Not a fit: People who are immunocompromised, currently ill, under 18, or with a history of Cryptosporidium infection are unlikely to benefit from participating in this controlled-exposure trial.

Why it matters

Potential benefit: If successful, EDI048 could shorten the duration or reduce the severity of diarrhea and other symptoms from cryptosporidiosis and inform treatment for children.

How similar studies have performed: Controlled human infection models and existing drugs like nitazoxanide have provided some proof-of-concept for treating cryptosporidiosis, but testing a new chemical entity such as EDI048 in this model is relatively novel.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland

• Pharmaron Inc — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

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