CRMA-1001 IV gene therapy in adults with chronic hepatitis B
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 study will test whether intravenous CRMA-1001, an epigenetic gene therapy, is safe and shows antiviral activity in adults with chronic hepatitis B who remain on oral antivirals.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | nChroma Bio Industry-sponsored |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT07200193 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1/2 trial gives adults with chronic hepatitis B single or multiple intravenous doses of CRMA-1001 in escalating dose levels followed by a dose-expansion cohort. The primary goal is to determine safety and tolerability across up to four dose levels while participants continue their oral antiviral therapy. The study will also characterize pharmacokinetics, pharmacodynamics, and early signs of antiviral activity. Participants must meet liver-function limits and are excluded if they have significant fibrosis, cirrhosis, or other non-HBV liver disease.
Who should consider this trial
Good fit: Adults 18–64 with chronic hepatitis B who are stable on oral antiviral therapy, have near-normal liver blood tests, and do not have significant fibrosis or other liver disease.
Not a fit: People with advanced fibrosis or cirrhosis, other non-HBV liver diseases, abnormal liver tests above protocol limits, or who fall outside the age/weight criteria are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, CRMA-1001 could provide a new way to lower HBV activity or alter viral gene expression beyond current antiviral pills.
How similar studies have performed: This epigenetic gene therapy approach for HBV is novel with limited clinical precedent, although other gene-silencing and immune-targeting HBV strategies have shown mixed early-stage signals.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Significant hepatic fibrosis or cirrhosis * Current or prior liver disease other than HBV * Other protocol-defined inclusion/exclusion criteria may apply
Where this trial is running
Hong Kong and 1 other locations
- Queen Mary Hospital, The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
- New Zealand Clinical Research — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: nChroma Bio
- Email: CRMA-1001-101-Study@nchromabio.com
- Phone: (617) 915 6203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.