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NCT07249463 · ClinicalTrials.gov registry record · Phase 2
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
A Phase 2 study of Cryptosporidiosis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT07249463: Recruiting Phase 2 study of Cryptosporidiosis, sponsored by Novartis Pharmaceuticals.
NCT07249463 is a Phase 2 study of Cryptosporidiosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07249463, a Phase 2 study of Cryptosporidiosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Cryptosporidium parvum oocysts (ABO809)
- DRUG EDI048
Study Locations (1)
Maryland
- Pharmaron Inc - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-12-08 |
| Est. Completion | 2027-03-02 |
| Phase | Phase 2 |
What NCT07249463 shows while recruiting
NCT07249463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Cryptosporidiosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07249463 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07249463 about?
NCT07249463 is a clinical study titled "Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults". 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 mod...
What is the current status of trial NCT07249463?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-12-08. Estimated completion is 2027-03-02.
What conditions does trial NCT07249463 study?
This clinical trial studies the following conditions: Cryptosporidiosis.
What interventions are being tested in trial NCT07249463?
The interventions under investigation include: Placebo (OTHER), Cryptosporidium parvum oocysts (ABO809) (BIOLOGICAL), EDI048 (DRUG).
Who is sponsoring clinical trial NCT07249463?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07249463 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cryptosporidiosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07249463's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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