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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06385327 | A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes | PHASE1 | COMPLETED | 115 | — | — | May 30, 2024 | Feb 3, 2026 | Mar 30, 2026 | 15 | Australia, New Zealand |
| Arm | Type | Description |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-5366 | EXPERIMENTAL | Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 |
| Part A: SAD Cohorts 1-5, Placebo | PLACEBO_COMPARATOR | Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 |
| Part A: SAD Fed Cohort 6, ABI-5366 | EXPERIMENTAL | Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect |
| Part B: MAD Cohorts 1-4 ABI-5366 | EXPERIMENTAL | Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
| Part B: MAD Cohorts 1-4 Placebo | PLACEBO_COMPARATOR | Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
| Name | Type | Description |
|---|---|---|
| ABI-5366 | DRUG | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) |
| ABI-5366 Placebo | DRUG | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) |
Part A: Inclusion Criteria: * Subject has a body mass index (BMI) between ≥ 18.0 and \< 32.0 kg/m2 * In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results. * Female subjects must be non-pregnant and have a negative se...