> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-tolerability-pk-pd-of-ab-101-following-oral-62710342-4ca1-4bdd-8488-fb9d230b68aa > Record changed: 2026-11-04 # Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. NCT05960240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Participants 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Lead sponsor Arbutus Biopharma Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Start date 2023-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Short title** Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Official title** A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Dates **Completion date** 2026-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **First posted** 2023-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Primary completion date** 2025-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Start date** 2023-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Size and sites **Actual participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Lead sponsor** Arbutus Biopharma Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Identifiers **Registry ID** NCT05960240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **ClinicalTrials.gov ID** NCT05960240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Outcomes ### Primary outcomes 1. Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs. Timeframe: \[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days\] 2. Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs Timeframe: \[Time Frame: Up to 196 days\] 3. Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Timeframe: \[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days\] 4. Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) Timeframe: \[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days\] 5. Part 3: Incidence of clinically significant laboratory abnormalities Timeframe: \[Time Frame: Up to 196 days\] 6. Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) Timeframe: \[Time Frame: Up to 196 days\] Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria Part 1 and 2 (Healthy Volunteers) - Male between ages 18-50 years - Willing and able to provide informed consent Willing to follow protocol-specified contraception requirement ### Inclusion criteria Part 3 (CHB Subjects) - Male or female subjects between the ages of 18-60 years - Willing to provide informed consent - Chronic HBV infection for at least 6 months - Willing to follow protocol-specified contraception requirement ### Exclusion criteria Part 1 and 2 (Healthy Volunteers) Key Exclusion Criteria: - Clinically significant lab abnormalities - A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease. - HIV or Hep C positive - Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test. ### Exclusion criteria Part 3 (CHB Subjects) - Have extensive fibrosis or cirrhosis of the liver - Have or had liver cancer (hepatocellular carcinoma) - Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study - Females who breastfeeding, pregnant or who wish to become pregnant during the study - Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Sites - Prince of Wales HospitalHong Kong, Hong Kong - Queen Mary Hospital - PPDSHong Kong, Hong Kong - ASST Papa Giovanni XXIII -OsepedaleBergamo, Italy - Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoMilan, Italy - Clinial Republican Hospital "Timofei Mosneaga"Chisinau, Moldova - New Zealand Clinical Research AucklandGrafton, New Zealand - Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.Bucharest, Romania - National University HospitalSingapore, Singapore - Singapore General HospitalSingapore, Singapore - Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City CouncilKyiv, Ukraine Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05960240) ## Related records ### Drugs (1) - [AB-101](https://trialight.com/data/asset/ab-101-748c859b-d308-48c5-8e30-c43dc52f1278.md) ### Lead sponsors (1) - [Arbutus Biopharma Corporation](https://trialight.com/data/company/arbutus-biopharma-corporation-6e383083-64cd-40f3-b30d-c0f9768c4a08.md) ### Conditions (1) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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