Testing CRMA-1001 gene therapy in adults with chronic hepatitis B
Tests CRMA-1001, a gene therapy given through a vein, in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Key facts
- Where
- Lyon Cedex 04, FranceSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07200193, who can take part
Where in France
- Hospices Civils De LyonLyon Cedex 04, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- nChroma Bio
- Trial code
- NCT07200193EU 2025-523619-12-00
- Record updated
- 15 June 2026
- Original description
This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.Read full original descriptionShow less
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
This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.
Inclusion: Male/Female, weight 45-150 kg, age 18-64, inclusive; Diagnosed with Chronic Hepatitis B; On oral antiviral therapy; ALT and AST <= 1.5 x ULN; Total bilirubin <= ULN.
Exclusion: Current or prior liver disease other than HBV; Significant hepatic fibrosis or cirrhosis; Other protocol-defined inclusion/exclusion criteria may apply.