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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04775797
Other study ID # AB-836-001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 25, 2021
Est. completion date November 17, 2022

Study information

Verified date November 2022
Source Arbutus Biopharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b 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.


Recruitment information / eligibility

Status Terminated
Enrollment 110
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy Subjects 1. Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old 2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results. 3. BMI of 18-32 kg/m2. - CHB Subjects: 1. Male or female between 18 and 65 years old. 2. 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 3. For cohort F, G, H: 1. HBV DNA =2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment). 2. ALT = 5x ULN 4. For Cohort I: 1. HBV DNA <LLOQ at Screening 2. 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. 3. ALT = 2.5 x ULN 5. HbsAg =250 IU/mL at screening Exclusion Criteria: - CHB Subjects 1. 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. 2. Co-infection with HIV or other non-B hepatitis viruses. 3. Any clinically significant or unstable medical condition or illness that could confound study findings. 4. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding. 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AB-836
Capsules or Tablets
Placebo
Capsules of Tablets
AB-836
Tablets
Placebo
Tablets
Nucleos(t)ide Analogue
Tablets

Locations

Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Nepean Hospital Kingswood New South Wales
Canada Ottawa Hospital Research Institute Ottawa Ontario
Canada Toronto Liver Center Toronto Ontario
Hong Kong Queen Mary Hospital Hong Kong
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Asan Medical Center Seoul
Moldova, Republic of Arensia Exploratory Medicine Chisinau
New Zealand New Zealand Clinical Research Auckland Auckland
Thailand Hospital For Tropical Diseases Bangkok
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai
Thailand Srinagarind Hospital Khon Kaen
Thailand Naresuan University Hospital Phitsanulok
Ukraine Medical Center of Limited Liability Company Arensia Exploratory Medicine Kyiv

Sponsors (1)

Lead Sponsor Collaborator
Arbutus Biopharma Corporation

Countries where clinical trial is conducted

Australia,  Canada,  Hong Kong,  Korea, Republic of,  Moldova, Republic of,  New Zealand,  Thailand,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of TEAEs Up to 35 days after last dose of AB-836/placebo
Primary Incidence of discontinuations due to AEs Up to 35 days after last dose of AB-836/placebo
Primary Incidence of lab abnormalities Up to 35 days after last dose of AB-836/placebo
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