A Study of the Safety, Tolerability, PK, PD, and Efficacy of CRMA‑1001 in Chronic Hepatitis B
Research type
Research Study
Full title
A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults with Chronic Hepatitis B
IRAS ID
1012668
Contact name
Elisabeta Moldoveanu
Contact email
Sponsor organisation
nChroma Bio
Eudract number
2025-523619-12
Research summary
CRMA-1001 is an experimental drug designed to target HBV DNA and turn off its ability to make new viruses and viral proteins. This study (CRMA-1001-101) will be conducted to evaluate the safety, tolerability and efficacy of CRMA-1001 in adults with chronic hepatitis B. In addition, levels of CRMA-1001 in blood and any effects that it has on HBV DNA and viral proteins in blood will be measured. Participants will receive one or three intravenous (IV) infusions of CRMA-1001, depending on which group they are enrolled in. The study will test up to four different dose levels.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0192
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion