A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 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
nChroma Bio
66 participants
Dec 22, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria2
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
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Interventions
Epigenetic gene silencing therapy delivered by intravenous (IV) infusion
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07200193