Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XEP527 · 1 trial · 1 indication
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Level 1 XEP527 | EXPERIMENTAL | Cohort 1: Dose Level 1 XEP527 |
| Cohort 2: Dose Level 2 XEP527 | EXPERIMENTAL | Cohort 2: Dose Level 2 XEP527 |
| Cohort 3: Dose Level 3 XEP527 | EXPERIMENTAL | Cohort 3: Dose Level 3 XEP527 |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Placebo |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Placebo |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| XEP527 | DRUG | Participants will receive XEP527 |
| Placebo | DRUG | Placebo |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * Participants 18 to 65 years of age, inclusive at screening * Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization * Participant has a primary dia...
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