Clinical trial NCT05960240: Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Arbutus Biopharma Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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]
measure: Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
timeFrame: [Time Frame: Up to 196 days]
measure: 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]
measure: 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]
measure: Part 3: Incidence of clinically significant laboratory abnormalities
timeFrame: [Time Frame: Up to 196 days]
measure: 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]
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital - Hong Kong
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital - PPDS
city: Chișinău
country: Moldova, Republic of
facility: Clinial Republican Hospital "Timofei Mosneaga"
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research Auckland
state: Auckland
city: Kyiv
country: Ukraine
facility: Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council
Study officials:
References: