Chronic HepatitisPhase 1NCT04775797
Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection
A Phase 1 study testing AB-836 and Nucleos(t)ide Analogue in people with Chronic Hepatitis, run by Arbutus Biopharma Corporation at 15 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis
- What is being tested?
- AB-836 and Nucleos(t)ide Analogue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 15 sitesin 8 countries
- Study dates
- 25 Jun 2021to 17 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects
- Male and Female (not of childbearing potential in Part 1 and 2a) subjects 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.
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- 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:
- HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Thailand5 sites
Hospital For Tropical Diseases
Bangkok
King Chulalongkorn Memorial Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Srinagarind Hospital
Khon Kaen
Naresuan University Hospital
Phitsanulok
Australia2 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales
Nepean Hospital
Kingswood, New South Wales
Canada2 sites
Ottawa Hospital Research Institute
Ottawa, Ontario
Toronto Liver Center
Toronto, Ontario
South Korea2 sites
Pusan National University Hospital
Busan
Asan Medical Center
Seoul
Ukraine1 site
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-836, an HBV Capsid Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection
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.
- Conditions
- Chronic Hepatitis
- Being tested
- AB-836, Placebo, Nucleos(t)ide Analogue
- Medical subject headings
- Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-836Drug
Capsules or Tablets
PlaceboDrug
Capsules of Tablets
AB-836Drug
Tablets
PlaceboDrug
Tablets
Nucleos(t)ide AnalogueDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Healthy Subjects): Single Ascending Dose (SAD) | Experimental | Two cohorts (Cohorts A and B) of healthy subjects will receive single doses of AB-836/placebo in an alternating cohort design under fasted conditions. One additional treatment will be administered under fed conditions. Receives: Drug: AB-836; Drug: Placebo |
| Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD) | Experimental | Participants in Cohorts C, D and E will receive a once daily dose of AB-836/placebo for 10 days Receives: Drug: AB-836; Drug: Placebo |
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H | Experimental | Participants in Cohorts F, G, and H will receive multiple doses of AB-836/placebo once daily for 28 days. Receives: Drug: AB-836; Drug: Placebo |
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I | Experimental | Participants in Cohort I will receive multiple doses of AB-836/placebo once daily for 28 days in combination with ongoing nucleos(t)ide analog (NA) therapy. Receives: Drug: AB-836; Drug: Placebo; Drug: Nucleos(t)ide Analogue |
| Part 2b (Healthy Subjects): MAD | Experimental | Participants in Cohorts J will receive a once daily dose of AB-836/placebo for 35 days Receives: Drug: AB-836; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
Measured: Up to 35 days after last dose of AB-836/placebo
Incidence of discontinuations due to AEs
Measured: Up to 35 days after last dose of AB-836/placebo
Incidence of lab abnormalities
Measured: Up to 35 days after last dose of AB-836/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 Jun 2021
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Why it stopped: Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775797
- Sponsor's protocol ID
- AB-836-001
- Status last verified
- Nov 2022
- First submitted
- 24 Feb 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-836, an HBV Capsid Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT04775797
- Acronym / sponsor ID
- AB-836-001
- Conditions
- Chronic Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Healthy Subjects): Single Ascending Dose (SAD) | Experimental | Drug: AB-836, Drug: PlaceboTwo cohorts (Cohorts A and B) of healthy subjects will receive single doses of AB-836/placebo in an alternating cohort design under fasted conditions. One additional treatment will be administered under fed conditions. |
| Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD) | Experimental | Drug: AB-836, Drug: PlaceboParticipants in Cohorts C, D and E will receive a once daily dose of AB-836/placebo for 10 days |
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H | Experimental | Drug: AB-836, Drug: PlaceboParticipants in Cohorts F, G, and H will receive multiple doses of AB-836/placebo once daily for 28 days. |
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I | Experimental | Drug: AB-836, Drug: Placebo, Drug: Nucleos(t)ide AnalogueParticipants in Cohort I will receive multiple doses of AB-836/placebo once daily for 28 days in combination with ongoing nucleos(t)ide analog (NA) therapy. |
| Part 2b (Healthy Subjects): MAD | Experimental | Drug: AB-836, Drug: PlaceboParticipants in Cohorts J will receive a once daily dose of AB-836/placebo for 35 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy Subjects
- CHB Subjects:
Key exclusion criteria (6 listed)
- CHB Subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-836Capsules or Tablets | Drug | Part 1 (Healthy Subjects): Single Ascending Dose (SAD) |
| PlaceboCapsules of Tablets | Drug | Part 1 (Healthy Subjects): Single Ascending Dose (SAD) |
| AB-836Tablets | Drug | Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD), Part 2b (Healthy Subjects): MAD, Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I, Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H |
| PlaceboTablets | Drug | Part 2a (Healthy Subjects): Multiple Ascending Dose (MAD), Part 2b (Healthy Subjects): MAD, Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I, Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H |
| Nucleos(t)ide AnalogueTablets | Drug | Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I |
Primary outcome
Incidence of TEAEs
Time frame: Up to 35 days after last dose of AB-836/placebo
Incidence of discontinuations due to AEs
Time frame: Up to 35 days after last dose of AB-836/placebo
Incidence of lab abnormalities
Time frame: Up to 35 days after last dose of AB-836/placebo
Results and safety
The study was stopped early (reason given: Safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-836 and Nucleos(t)ide Analogue in people with Chronic Hepatitis, run by Arbutus Biopharma Corporation at 15 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Thailand, Australia, Canada, South Korea, Hong Kong and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: Up to 35 days after last dose of AB-836/placebo). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.