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NCT05036668 · ClinicalTrials.gov registry record · Phase 1
Study of Efficacy and Safety of ABO809 in Healthy Participants
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05036668 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants.
The verdict
NCT05036668, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).
Interventions
- BIOLOGICAL Cryptosporidium parvum oocysts (ABO809)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2022-12-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05036668
The ClinicalTrials.gov registry entry for NCT05036668 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cryptosporidium parvum oocysts (ABO809) is the first listed.
NCT05036668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05036668 about?
NCT05036668 is a clinical study titled "Study of Efficacy and Safety of ABO809 in Healthy Participants". The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study me...
What is the current status of trial NCT05036668?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-04-07. Estimated completion is 2022-12-27.
What interventions are being tested in trial NCT05036668?
The interventions under investigation include: Cryptosporidium parvum oocysts (ABO809) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05036668?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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