Safety Tolerability and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    60
  • sponsor
    Arbutus Biopharma Corporation
Updated on 24 July 2021

Summary

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

Details
Condition Chronic hepatitis
Treatment Placebo, Tenofovir disoproxil fumarate, AB-836
Clinical Study IdentifierNCT04775797
SponsorArbutus Biopharma Corporation
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy Subjects
Male subjects or female subjects not of childbearing potential between 18 and 45 years old
Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results
BMI of 18-32 kg/m2
CHB Subjects
Male or female between 18 and 65 years old
Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection
For cohort F, G, H and J
HBV DNA 2,000 IU/mL at Screening (subjects may be either treatment-nave or treatment-experienced but currently off-treatment)
ALT 5x ULN
For Cohort I
HBV DNA <LLOQ at Screening
Subjects must have been receiving either TAF, TDF, or ETV consistently for 6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit
ALT 2.5 x ULN
HbsAg 250 IU/mL at screening

Exclusion Criteria

CHB Subjects
Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease
Co-infection with HIV or other non-B hepatitis viruses
Any clinically significant or unstable medical condition or illness that could confound study findings
Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding
Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier [CpAM or CAM]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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