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This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-H0731 or Matching Placebo | Experimental | ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days |
|
| ABI-H0731 or Placebo and ETV or TDF | Experimental | ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days |
|
| ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys | Experimental | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H0731 | Drug |
|
| 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 57 days |
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Healthy volunteers:
CHB patients:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland | New Zealand | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31711752 | Derived | Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo for ABI-H0731 | Drug |
|
|
| Entecavir | Drug | Used to treat adults with chronic hepatitis B virus |
|
| Tenofovir disoproxil fumarate | Drug | Used to treat adults with chronic hepatitis B virus |
|
| Pegasys | Drug | Used to treat adults with chronic hepatitis B virus who show signs of liver damage |
|
|
| Nucleos(t)ide | Drug | Used to treat adults with chronic hepatitis B virus |
|
| Hamilton |
| New Zealand |
| 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 |
| D000225 |
| Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |