Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
NCT05867056 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-10-15
Summary
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB). This is the first in-human study of IMC-I109V in persons with CHB.
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
IMC-I109V Single Ascending Dose
Single dose administration of IMC-I109V
- DRUG
-
IMC-I109V Multiple Ascending Doses
Multidose administration of IMC-I109V
- DRUG
-
HBV HCC Module MAD
Multidose administration of IMC-I109V
Sponsors & Collaborators
-
Immunocore Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-12
- Primary Completion
- 2024-09-10
- Completion
- 2024-12-15
- FDA Drug
- Yes
Countries
- United States
- Australia
- Denmark
- Hong Kong
- Romania
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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