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This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-H2158 | Experimental | ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days |
|
| Matching Placebo for ABI-H2158 | Placebo Comparator | Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H2158 | Drug | 5 mg or 25 mg tablets |
| |
| Placebo for ABI-H2158 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0. | Up to 28 days |
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Healthy volunteers:
Chronic HBV patients:
Key Inclusion Criteria:
Male or female ≥ 18 and ≤ 65 years of age.
In good general health except for chronic HBV infection, documented by:
Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | United States | ||
| Research and Education |
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| Drug |
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets |
|
| San Diego |
| California |
| 92115 |
| United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Infectious Disease Care | Hillsborough | New Jersey | 08844 | United States |
| Monash University | Clayton | Victoria | Australia |
| The Alfred Hospital | Melbourne | Victoria | Australia |
| Linear Clinical Research | Nedlands | Western Australia | Australia |
| First Hospital of Jilin University | Jilin City | Changchun | 130000 | China |
| University of Hong Kong, Queen Mary Hospital | Hong Kong | Hong Kong |
| Auckland Clinical Studies | Auckland | New Zealand |
| Hallym University | Chuncheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Severance Hospital, Yonsei University | Seoul | South Korea |
| King's College London | London | United Kingdom |
| 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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