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Safety
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This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Healthy Subjects): Single Ascending Dose (SAD) | Experimental | Two cohorts (Cohorts A and B) of healthy subjects will receive single doses of AB-836/placebo in an alternating cohort design under fasted conditions. One additional treatment will be administered under fed conditions. |
|
| Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD) | Experimental | Participants in Cohorts C, D and E will receive a once daily dose of AB-836/placebo for 10 days |
|
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H | Experimental | Participants in Cohorts F, G, and H will receive multiple doses of AB-836/placebo once daily for 28 days. |
|
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I | Experimental | Participants in Cohort I will receive multiple doses of AB-836/placebo once daily for 28 days in combination with ongoing nucleos(t)ide analog (NA) therapy. |
|
| Part 2b (Healthy Subjects): MAD | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-836 | Drug | Capsules or Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs | Up to 35 days after last dose of AB-836/placebo | |
| Incidence of discontinuations due to AEs | Up to 35 days after last dose of AB-836/placebo | |
| Incidence of lab abnormalities | Up to 35 days after last dose of AB-836/placebo |
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Inclusion Criteria:
Healthy Subjects
CHB Subjects:
Male or female between 18 and 65 years old.
Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection
For cohort F, G, H:
For Cohort I:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | |||
| Nepean Hospital |
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Single blind only (Participant) in Part 2b
Participants in Cohorts J will receive a once daily dose of AB-836/placebo for 35 days
|
| Placebo |
| Drug |
Capsules of Tablets |
|
| AB-836 | Drug | Tablets |
|
| Placebo | Drug | Tablets |
|
| Nucleos(t)ide Analogue | Drug | Tablets |
|
| Kingswood |
| New South Wales |
| Australia |
| Ottawa Hospital Research Institute | Ottawa | Ontario | Canada |
| Toronto Liver Center | Toronto | Ontario | Canada |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Arensia Exploratory Medicine | Chisinau | Moldova |
| New Zealand Clinical Research Auckland | Auckland | New Zealand |
| Pusan National University Hospital | Busan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Hospital For Tropical Diseases | Bangkok | Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand |
| Srinagarind Hospital | Khon Kaen | Thailand |
| Naresuan University Hospital | Phitsanulok | Thailand |
| Medical Center of Limited Liability Company Arensia Exploratory Medicine | Kyiv | Ukraine |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| 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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