Actively Recruiting
A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Led by nChroma Bio · Updated on 2026-01-29
66
Participants Needed
2
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 to 64 years inclusive
- Weight between 45 and 150 kg
- Diagnosed with Chronic Hepatitis B
- Currently receiving oral antiviral therapy
- ALT and AST levels less than or equal to 1.5 times the upper limit of normal
- Total bilirubin less than or equal to the upper limit of normal
You will not qualify if you...
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than Hepatitis B
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, 999077
Actively Recruiting
2
New Zealand Clinical Research
Auckland, New Zealand
Actively Recruiting
Research Team
N
nChroma Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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