Status:
NOT_YET_RECRUITING
A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Lead Sponsor:
nChroma Bio
Conditions:
Chronic Hepaititis B
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07200193
Start Date
January 1 2026
End Date
December 31 2032
Last Update
September 30 2025
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