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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06740474 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants | PHASE1 | COMPLETED | 40 | — | — | Jan 31, 2025 | Jul 8, 2025 | Dec 4, 2025 | 1 | New Zealand |
| Arm | Type | Description |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-6250 | EXPERIMENTAL | - |
| Part A: SAD Cohorts 1-5, Placebo | PLACEBO_COMPARATOR | - |
| Part A: SAD Food Effect Cohort 6 or 7: ABI-6250 | EXPERIMENTAL | - |
| Part A: SAD Food Effect Cohort 6 (if applicable): Placebo | PLACEBO_COMPARATOR | - |
| Part B: MAD Cohorts 1-4, ABI-6250 | EXPERIMENTAL | - |
| Part B: MAD Cohorts 1-4, Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABI-6250 | DRUG | Single dose (SAD) or once or twice daily dosing over 10 days (MAD) |
| Placebo | DRUG | Single dose (SAD) or once or twice daily dosing over 10 days (MAD) |
Inclusion Criteria: * Participant has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results. * Female participants must be non-pregnant and have a negative...