Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

Conditions

• Hepatitis B, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Imdusiran — DRUG
  subcutaneous injection
• Durvalumab — DRUG
  intravenous injection

Study Details

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

Key Dates

Start date

May 1, 2024

Status verified

Jun 2024

Primary completion

Aug 1, 2024

Completion

Aug 1, 2024

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
• Experimental: Cohort B
  Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
• Experimental: Cohort C
  Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints

Primary Outcome Measure

To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects [ Time Frame: Up to 96 weeks ]