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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
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.
A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.
Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.
Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
Queen Mary Hospital - PPDS
Hong Kong, Hong Kong, Hong Kong
ASST Papa Giovanni XXIII -Osepedale
Bergamo, Italy
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: [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: [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: [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: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
Time frame: [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: [Time Frame: Up to 196 days]
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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