Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection

NCT05867056 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-10-15

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867056 on ClinicalTrials.gov