CryptosporidiosisPhase 2CRYPTONITENCT07249463
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
A Phase 2 study testing Cryptosporidium parvum oocysts (ABO809) and EDI048 in people with Cryptosporidiosis, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryptosporidiosis
- What is being tested?
- Cryptosporidium parvum oocysts (ABO809) and EDI048
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2025to 23 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States2 sites, 2 recruiting
- Recruiting
Pharmaron Inc
Baltimore, Maryland, 21201
Caroline Sarnecki, +1 410 245 6888, caroline.sarnecki@pharmaron.com
Charmagne Beckett
- Recruiting
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039
Michelle Dickey, +1 800 344 2462, Michelle.Dickey@cchmc.org
Robert Frenck
About this study
Official title: 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.
Read the 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.
- Conditions
- Cryptosporidiosis
- Being tested
- Cryptosporidium parvum oocysts (ABO809), EDI048, Placebo
- Keywords
- Cryptosporidiosis, Cryptosporidium, EDI048, ABO809, Controlled human infection model, CHIM
- Medical subject headings
- Cryptosporidiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryptosporidium parvum oocysts (ABO809)Biological
ABO809 oral suspension, single dose
EDI048Drug
EDI048 administered orally
PlaceboOther
Placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Cryptosporidium parvum oocysts (ABO809); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3, Day 4 and Day 5
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to Day 35
PK parameter: Cmax
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: Tmax
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: AUC0-t
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: AUClast
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: AUCinf
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: T1/2
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: CI/F
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
PK parameter: V/F
To characterize PK of EDI048 and metabolite QPL621.
Measured: up to Day 5
Number of participants with adverse events of special interest (AESIs)
To assess the safety and tolerability of EDI048 vs. placebo.
Measured: up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start8 Dec 2025
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptosporidiosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249463
- Sponsor's protocol ID
- CEDI048A12201
- Acronym
- CRYPTONITE
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07249463
- Acronym / sponsor ID
- CRYPTONITE / CEDI048A12201
- Conditions
- Cryptosporidiosis
- Keywords
- Cryptosporidiosis, Cryptosporidium, EDI048, ABO809, Controlled human infection model, CHIM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDI048 | Experimental | Biological: Cryptosporidium parvum oocysts (ABO809), Drug: EDI048Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally. |
| Placebo | Placebo comparator | Biological: Cryptosporidium parvum oocysts (ABO809), Other: PlaceboParticipants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryptosporidium parvum oocysts (ABO809)ABO809 oral suspension, single dose | Biological | EDI048, Placebo |
| EDI048EDI048 administered orally | Drug | EDI048 |
| PlaceboPlacebo administered orally | Other | Placebo |
Primary outcome
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.
17 secondary outcomes
Maximum stool grade after the initiation of EDI048 or placebo treatment
Time frame: Day 3, Day 4 and Day 5
Time to resolution of clinical diarrheal illness
Time frame: up to Day 35
Number of participants with associated gastrointestinal symptoms
Time frame: up to Day 35
Number of diarrhea episodes per participant
Time frame: up to Day 35
Overall diarrheal stool weight
Time frame: up to Day 35
Stool grade by stool grade category
Time frame: up to Day 35
Number of participants with fecal shedding of Cryptosporidium parvum oocysts
Time frame: 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
PK parameter: Cmax
Time frame: up to Day 5
PK parameter: Tmax
Time frame: up to Day 5
PK parameter: AUC0-t
Time frame: up to Day 5
PK parameter: AUClast
Time frame: up to Day 5
PK parameter: AUCinf
Time frame: up to Day 5
PK parameter: T1/2
Time frame: up to Day 5
PK parameter: CI/F
Time frame: up to Day 5
PK parameter: V/F
Time frame: up to Day 5
Number of participants with adverse events of special interest (AESIs)
Time frame: up to Day 35
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryptosporidium parvum oocysts (ABO809) and EDI048 in people with Cryptosporidiosis, run by Novartis Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average stool grade after the initiation of EDI048 or placebo treatment (time frame: Day 3, Day 4 and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.