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AB-101 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AB-101 | DRUG | AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents. |
| Placebo | DRUG | A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study. |
| Nucleos(t)ide Analogue | DRUG | Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B. |
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 ...
AB-101 is an investigational oral small molecule being developed by Arbutus Biopharma Corporation for chronic hepatitis B. It is designed as an immune-modulating agent and has completed a Phase 1 clinical trial in healthy volunteers and subjects with chronic hepatitis B. It is not yet approved for any indication.
AB-101 targets PD-1, a protein receptor that normally restrains T cell activity. By binding PD-1, AB-101 is intended to block this checkpoint and restore immune responses against hepatitis B virus. This mechanism is being evaluated in chronic hepatitis B, where exhausted T cells limit viral control.
AB-101 is being developed by Arbutus Biopharma Corporation, a clinical-stage biopharmaceutical company that trades on the Nasdaq under the ticker symbol ABUS. Arbutus is focused on advancing therapies for chronic hepatitis B and other infectious diseases.
AB-101 is in Phase 1 development. A single Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory authority for chronic hepatitis B or any other indication.
AB-101 has been studied in one completed Phase 1 trial, NCT05960240, titled Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. The trial enrolled 128 participants across Hong Kong, Italy, Moldova, New Zealand, Romania, Singapore, and Ukraine, and included healthy volunteers and subjects with chronic hepatitis B.