A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B

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 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

Conditions2

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