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Cryptosporidium parvum oocysts · 2 trials · 2 indications
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| ABO809 | EXPERIMENTAL | Participants will receive ABO809 at a single oral dose of 1x10\^4 oocysts. Other doses such as 1x10\^6 oocysts may be considered to optimize the model |
| Name | Type | Description |
|---|---|---|
| Cryptosporidium parvum oocysts (ABO809) | BIOLOGICAL | ABO809 oral suspension, single dose |
| EDI048 | DRUG | EDI048 administered orally |
| Placebo | OTHER | Placebo administered orally |
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 ...