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

Last updated: January 2, 2025
Sponsor: Arbutus Biopharma Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

Placebo

Nucleos(t)ide Analogue

AB-101

Clinical Study ID

NCT05960240
AB-101-001
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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 otherimmune-mediated disease.

  • HIV or Hep C positive

  • Known chronic or severe infection or recent significant exposure to infections suchas 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 immunosuppressivemedications 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 suchas tuberculosis or endemic mycosis, untreated latent infections like tuberculosis,or a positive or indeterminate QuantiFERON test.

Study Design

Total Participants: 164
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
August 30, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Prince of Wales Hospital - Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital - PPDS

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Clinial Republican Hospital "Timofei Mosneaga"

    Chișinău,
    Moldova, Republic of

    Active - Recruiting

  • New Zealand Clinical Research Auckland

    Grafton, Auckland 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research Auckland

    Auckland,
    New Zealand

    Site Not Available

  • Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council

    Kyiv,
    Ukraine

    Active - Recruiting

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