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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06384131 | A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection | PHASE1 | COMPLETED | 20 | — | — | Jun 4, 2024 | May 14, 2025 | Jul 23, 2025 | 2 | Moldova, New Zealand |
| NCT05569941 | A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects | PHASE1 | COMPLETED | 54 | — | — | Nov 11, 2022 | Apr 12, 2023 | Sep 13, 2023 | 1 | New Zealand |
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
| Arm | Type | Description |
|---|---|---|
| ABI-4334 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Part A: SAD Cohorts 1-5 ABI-4334 Tablet | EXPERIMENTAL | A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts. |
| Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-4334 will be administered on Day 1. |
| Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet | EXPERIMENTAL | A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5. |
| Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6. |
| Part B: MAD Cohorts 1-2 ABI-4334 Tablet | EXPERIMENTAL | Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts. |
| Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8. |
| Name | Type | Description |
|---|---|---|
| ABI-4334 | DRUG | 10 mg or 50 mg tablets for oral administration |
| Placebo | DRUG | 10 mg or 50 mg tablets for oral administration |
| ABI-4334 Tablet | DRUG | ABI-4334 Tablet |
| ABI-4334 Placebo | DRUG | Placebo to ABI-4334 Tablet |
Inclusion Criteria: 1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg 2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented 3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prio...