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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Cryptosporidiosis
• Intervention / Treatment: Biological: Cryptosporidium parvum oocysts (ABO809); Drug: EDI048; Other: Placebo

Detailed Description

This study is a Placebo-controlled, participant- and investigator-blinded multicenter trial in healthy adult volunteers who are administered Cryptosporidium parvum oocysts (ABO809) to develop diarrhea and symptoms consistent with cryptosporidiosis. After developing diarrhea, participants will be randomized 1:1 to treatment with EDI048 or placebo in parallel.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Pharmaron Inc
      • Contact: Caroline Sarnecki; Phone Number: 410-245-6888; Email: caroline.sarnecki@pharmaron.com
      • Principal Investigator: Charmagne Beckett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Cryptosporidium parvum oocysts (ABO809); ABO809 oral suspension, single dose; Drug: EDI048; 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.	Biological: Cryptosporidium parvum oocysts (ABO809); ABO809 oral suspension, single dose; Other: Placebo; Placebo administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum 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
Time to resolution of clinical diarrheal illness	To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.	up to Day 35
Number of participants with associated gastrointestinal symptoms	To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.	up to Day 35
Number of diarrhea episodes per participant	To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.	up to Day 35
Overall diarrheal stool weight	To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.	up to Day 35
Stool grade by stool grade category	To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.	up to Day 35
Number of participants with fecal shedding of Cryptosporidium parvum oocysts	To evaluate the incidence of and time to resolution of Cryptosporidium infection in participants who received EDI048 vs. placebo.	up to Day 35
Number of oocysts per gram per day (wet and dry weight) and the total number of oocyst per day measured by qPCR in fecal samples	To quantify fecal shedding of oocysts in participants who received EDI048 vs. placebo and to assess time to resolution of infection.	up to Day 35
PK parameter: Cmax	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: Tmax	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: AUC0-t	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: AUClast	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: AUCinf	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: T1/2	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: CI/F	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
PK parameter: V/F	To characterize PK of EDI048 and metabolite QPL621.	up to Day 5
Number of participants with adverse events of special interest (AESIs)	To assess the safety and tolerability of EDI048 vs. placebo.	up to Day 35

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cryptosporidiosis; Controlled human infection model; Cryptosporidium; CHIM; EDI048; ABO809
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Protozoan Infections; Parasitic Diseases; Intestinal Diseases, Parasitic; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Animal Diseases; Cryptosporidiosis
• Other Study ID Numbers: CEDI048A12201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No