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

June 1, 2026 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Pharmaron Inc
        • Contact:
        • Principal Investigator:
          • Charmagne Beckett

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average stool grade after the initiation of EDI048 or placebo treatment
Time Frame: Day 3, Day 4 and Day 5
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum stool grade after the initiation of EDI048 or placebo treatment
Time Frame: Day 3, Day 4 and Day 5
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 35
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
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: Tmax
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: AUC0-t
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: AUClast
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: AUCinf
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: T1/2
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: CI/F
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
PK parameter: V/F
Time Frame: up to Day 5
To characterize PK of EDI048 and metabolite QPL621.
up to Day 5
Number of participants with adverse events of special interest (AESIs)
Time Frame: up to Day 35
To assess the safety and tolerability of EDI048 vs. placebo.
up to Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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