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This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-101 | Drug | AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs. | [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] | |
| Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs | [Time Frame: Up to 196 days] | |
| Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities | [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] | |
| Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) | [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] | |
| Part 3: Incidence of clinically significant laboratory abnormalities | [Time Frame: Up to 196 days] | |
| Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) | [Time Frame: Up to 196 days] |
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Inclusion Criteria: Part 1 and 2 (Healthy Volunteers)
Willing to follow protocol-specified contraception requirement
Inclusion Criteria: Part 3 (CHB Subjects)
Exclusion Criteria: Part 1 and 2 (Healthy Volunteers)
Key Exclusion Criteria:
Exclusion Criteria: Part 3 (CHB Subjects)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong | Hong Kong | |||
| Queen Mary Hospital - PPDS |
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| Placebo | Drug | A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study. |
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| Nucleos(t)ide Analogue | Drug | Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B. |
|
| Hong Kong |
| Hong Kong |
| Hong Kong |
| ASST Papa Giovanni XXIII -Osepedale | Bergamo | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | Italy |
| Clinial Republican Hospital "Timofei Mosneaga" | Chisinau | Moldova |
| New Zealand Clinical Research Auckland | Grafton | Auckland | New Zealand |
| Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M. | Bucharest | Romania |
| National University Hospital | Singapore | Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council | Kyiv | Ukraine |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| 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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