A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Recruiting · NCT07200193 · Interventional (participants receive a specific treatment) · Lead sponsor: nChroma Bio
View the official record on ClinicalTrials.gov →Interventions studied
CRMA-1001
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.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- New Zealand Clinical Research - Auckland, New Zealand
- Queen Mary Hospital, The University of Hong Kong - Hong Kong, Hong Kong
- King's College Hospital - London, United Kingdom
- Hospices Civils De Leon - Lyon, France