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

Arbutus Biopharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: AB-101; Drug: Nucleos(t)ide Analogue; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05960240

AB-101-001

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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 other immune-mediated disease.
• HIV or Hep C positive
• Known chronic or severe infection or recent significant exposure to infections such as 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 immunosuppressive medications 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 such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 3 patient groups

Part 1

Experimental group

Treatment:

Drug: Placebo

Drug: AB-101

Part 2

Experimental group

Treatment:

Drug: Placebo

Drug: AB-101

Part 3

Experimental group

Treatment:

Drug: Placebo

Drug: Nucleos(t)ide Analogue

Drug: AB-101