Phase 1
N=30
Study of Efficacy and Safety of ABO809 in Healthy Participants
Cryptosporidium Infection, Cryptosporidiosis
Bottom Line
View on ClinicalTrials.gov: NCT05036668 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration — 50; 57.1; 60.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cryptosporidium parvum oocysts (ABO809) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration |
50; 57.1; 60.0 | — |
| SECONDARY Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration |
60.0; 57.1; 50.0; 60.0; 57.1; 50.0 | — |
| SECONDARY Number of Diarrhea Stools Per Participant |
13.3; 16.2; 12.9 | — |
| SECONDARY Overall Diarrheal Stool Weight |
1614.0; 2681.6; 2877.0 | — |
| SECONDARY Maximum Stool Grade by Stool Grade Category |
0; 0; 1; 2; 2; 3 | — |
| SECONDARY Time to Onset of Clinical Diarrheal Illness |
3.3; 3.3; 2.8 | — |
| SECONDARY Time to Resolution of Clinical Diarrheal Illness |
9.0; 9.8; 10.0 | — |
| SECONDARY Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness |
1; 0; 0; 3; 0; 1 | — |
| SECONDARY Percentage of Participants With Cryptosporidium Infection From 72 Hours to Day 28 Post ABO809 Oral Administration |
60.0; 57.1; 60 | — |
| SECONDARY Percentage of Participants With Fecal Shedding of Cryptosporidium Parvum Oocysts |
60.0; 57.1; 60.0 | — |
| SECONDARY Time to Onset of Cryptosporidium Infection |
4.0; 4.0; 4.0 | — |
| SECONDARY Time to Resolution of Cryptosporidium Infection |
10.6; 10.8; 9.7 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
2; 2; 2; 2; 2; 2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
- Good health
- Ability to communicate well with the Investigator
Exclusion Criteria
- History of Cryptosporidium infection, gastrointestinal conditions (including diarrheal syndromes, gastroenteritis and gastrointestinal tract surgery), immunodeficiency, infections, significant medical concerns, hypersensitivity to nitazoxanide or other specified antibiotics.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05036668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.