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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511051-18 | EudraCT Number |
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This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-4334 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-4334 | Drug | 10 mg or 50 mg tablets for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses | Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results | Through end of study, up to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV | Noncompartmental plasma PK parameters | Through treatment period, up to 28 days |
| Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARENSIA Exploratory Medicine Chisinau | Chisinau | Moldova | ||||
| New Zealand Clinical Research |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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Triple (Participant, Care Provider, Investigator)
| Placebo |
| Drug |
10 mg or 50 mg tablets for oral administration |
|
Mean change in log10 HBV DNA between Baseline and Day 28 |
| Through treatment period, up to 28 days |
| To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV | Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV | Through treatment period, up to 28 days |
| To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV | Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV | Through treatment period, up to 28 days |
| Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV | Through treatment period, up to 28 days |
| Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV | To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV | Through treatment period, up to 28 days |
| Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 | Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD) | Through treatment period, up to 28 days |
| Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 | Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD | Through treatment period, up to 28 days |
| Auckland |
| New Zealand |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |