NCT06154278

Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B

Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA, Imdusiran (AB-729), Among People With Chronic Hepatitis B

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are: * how well is it working in the liver * how does Imdusiran affect the hepatitis B virus Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.

Detailed description

This is a single-center, non-randomized, pilot study of Imdusiran in adults with chronic hepatitis B on oral antiviral therapy. The primary objective of this study is to evaluate the intrahepatic concentrations of Imdusiran. The secondary objective is to evaluate the effect of Imdusiran on viral markers. Up to 10 participants will receive a total of 4 subcutaneous injections of 60mg Imdusiran (one injection every 8 weeks). They will undergo 2 liver biopsies: one with the first dose, and the second 8 weeks after the last dose. There is an optional third liver biopsy at the end of study (week 52).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Imdusiran (AB-729)	60mg subcutaneously, every 8 weeks, for a total of 4 doses

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2023-12-04
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study