Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

NCT05960240
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
128
clinicaltrials.gov
Lead sponsor
Arbutus Biopharma Corporation
clinicaltrials.gov
Start date
2023-08-30
clinicaltrials.gov
Number of sites
10
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
clinicaltrials.gov
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.
clinicaltrials.gov

Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2026-02-09
clinicaltrials.gov
First posted
2023-07-25
clinicaltrials.gov
Registry last updated
2026-04-13
clinicaltrials.gov
Primary completion date
2025-12-04
clinicaltrials.gov
Start date
2023-08-30
clinicaltrials.gov

Actual participants
128
clinicaltrials.gov
Participants
128
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
10
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Arbutus Biopharma Corporation
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05960240
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05960240
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Participants
Sources for study design
clinicaltrials.gov

  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
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
Yes

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

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

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.

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)