Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-101 Following Oral Administration in Healthy and Chronic Hepatitis B Subjects

Phase 1

Active, not recruiting

• Conditions: Chronic hepatitis B virus Infection
• Interventions: Drug: AB-101; Drug: Placebo; Drug: Nucleos(t)ide Analogue

• Registration Number: 2023-508312-39-00
• Lead Sponsor: Arbutus Biopharma Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-04
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 3	AB-101	-
Part 1	Placebo	-
Part 2	Placebo	-
Part 3	Nucleos(t)ide Analogue	-
Part 3	Placebo	-
Part 2	AB-101	-
Part 1	AB-101	-

Primary Outcome Measures

Name	Time	Method
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.	[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs	[Time Frame: Up to 196 days]
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities	[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)	[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities	[Time Frame: Up to 196 days]
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)	[Time Frame: Up to 196 days]

Trial Locations

Locations (5)

Umbal - Prof. D-R Stoyan Kirkovich AD; 🇧🇬 Stara Zagora, Bulgaria

Military Medical Academy; 🇧🇬 Sofiya, Bulgaria

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii; 🇮🇹 Bergamo, Italy

Institutul National De Boli Infectioase Prof.Dr.Matei Bals; 🇷🇴 Bucharest, Romania

Umbal - Prof. D-R Stoyan Kirkovich AD

🇧🇬Stara Zagora, Bulgaria

Mariana Radicheva

Site contact

+359888303318

dr.mradicheva@gmail.com