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

RecruitingPhase 1, Phase 2Ages 18 Years - 64 YearsAllnChroma Bio
NCT07200193 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • CRMA-1001
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Where

4 sites
Hospices Civils De Leon
Lyon, France
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
New Zealand Clinical Research
Auckland, New Zealand
King's College Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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