Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07249463 | Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults | PHASE2 | RECRUITING | 96 | — | — | Dec 8, 2025 | Mar 2, 2027 | Jun 2, 2026 | 1 | United States |
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
| 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. |
| 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 ...