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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000318-32 | 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-H3733 in treatment-naĂŻve 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-H3733 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-H3733 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H3733 | Drug | 25 mg or 100 mg tablets for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days | |
| Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diagnostic Consultative Center Aleksandrovska | Sofia | Sofia-Grad | 1431 | Bulgaria | ||
| Acibadem City Clinic Tokuda Hospital |
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| Placebo |
| Drug |
25 mg or 100 mg tablets for oral administration |
|
| Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
| Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
| Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
| To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
| To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
| To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results | Through treatment period, up to 28 days |
| To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR | Through treatment period, up to 28 days |
| Sofia |
| 1407 |
| Bulgaria |
| Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia | Sofia | 1606 | Bulgaria |
| University of Hong Kong | Hong Kong | Hong Kong |
| ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital | Chisinau | MD-2025 | Moldova |
| New Zealand Clinical Research | Grafton | Auckland | 1051 | New Zealand |
| Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals" | Bucharest | 021105 | Romania |
| Clinical Trials and Research Centre, Singapore General Hospital | Singapore | 168753 | Singapore |
| National University Hospital | Singapore | Singapore |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| 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 |
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