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The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467
Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative subjects and one cohort of HBeAg-positive subjects and 12 HbeAg-negative subjects will be enrolled in cohort 4. All subjects will be non-cirrhotic, with chronic hepatitis B virus (HBV) infection, and will have been receiving nucleos(t)ide-analogue (NA) therapy with entecavir or tenofovir for at least 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2 mg/kg ARB-001467 or Placebo | Experimental | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.2 mg/kg versus placebo once a month for 3 months |
|
| 0.4 mg/kg ARB-001467 or Placebo | Experimental | HBeAg-negative subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
|
| ARB-001467 or Placebo | Experimental | HBeAg-positive subjects randomized 3:1 to receive ARB-001467 at 0.4 mg/kg versus placebo once a month for 3 months |
|
| 0.4 mg/kg ARB-001467 | Experimental | HBeAg-negative subjects receive ARB-001467 at. 0.4 mg/kg (open label) bi-weekly for 5 treatments and then subjects with HBsAg ≤1000 IU/mL AND ≥1.0 log10 decrease from baseline at Day 71 will continue monthly dosing through 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARB-001467 | Drug | An IV infusion of ARB-001467 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment-emergent SAEs, discontinuations due to AEs, and laboratory abnormalities, by cohort, through 28 days after the last infusion of study treatment. | To evaluate the safety and tolerability of multiple doses of ARB-001467 in HBeAg-negative and HBeAg-positive subjects with chronic Hepatitis B virus infection who are receiving nucleos(t)ide analogue therapy | 28 days post last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate ARB-001467 Maximum plasma concentration (Cmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4). | To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection. | Up to 36 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Mendez, MD, PhD | Arbutus Biopharma Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Health, Gastroenterology and Hepatology | Clayton | Victoria | 3168 | Australia | ||
| The Alfred, Gastroenterology and Hepatology |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Single Blind (Subject) in cohort 1-3, Open label in Cohort 4
| Placebo | Other | An IV infusion of placebo |
|
|
| Evaluate ARB-001467 Time to maximum plasma concentration (Tmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4). |
To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection. |
| Up to 36 Weeks |
| Evaluate ARB-001467 Area under the plasma concentration-time curve from the start of infusion to the last measurable concentration (AUC0-t) at multiple time points from baseline through Day 85 (cohort 1-3) and Week 36 (Cohort 4). | To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection. | Up to 36 Weeks |
| Evaluate additional parameters for ARB-001467 from plasma concentration-time curve from start of infusion and extrapolated to infinity (AUC0-t), inf) partial, AUCs, T1/2, volume of distribution (VD) and clearance (CL) -baseline through Day 85 or Week 36. | To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection. | Up to 36 Weeks |
| Evaluate antiviral activity of ARB 001467 for up to 72 weeks after the first dose of study treatment. | The proportion of subjects in each dose level cohort with ≥0.5 log10 HBsAg decrease from baseline at EOS, and for these subjects, the changes from baseline (expressed as percentage and log10 change) in the following virologic markers will be assessed throughout the study:
For the HBeAg positive cohort only: - Quantitative HBV e antigen (HBeAg) | Up to 18 months |
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| Linear Clinical Research Ltd | Nedlands | Western Australia | 6009 | Australia |
| Auckland Clinical Studies Ltd | Auckland | 1010 | New Zealand |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |