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Clinical Trial NCT07200193 for Chronic Hepaititis B is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 Phase 1, Phase 2 66 Gene Therapy Open-Label
Clinical Trial NCT07200193 is designed to study Treatment for Chronic Hepaititis B. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 22 December 2025, with plans to enroll 66 participants. Led by nChroma Bio, it is expected to complete by 31 December 2032. The latest data from ClinicalTrials.gov was last updated on 29 January 2026.
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 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 intravenou...Show More
Official Title
A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B
Conditions
Chronic Hepaititis BOther Study IDs
- CRMA-1001-101
NCT ID Number
Start Date (Actual)
2025-12-22
Last Update Posted
2026-01-29
Completion Date (Estimated)
2032-12-31
Enrollment (Estimated)
66
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
CHB
Chronic hepatitis B
Chronic HBV
Chronic Hep B
Chronic hepatitis
HBV
Chronic hepatitis B
Chronic HBV
Chronic Hep B
Chronic hepatitis
HBV
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCRMA-1001 Part A, SAD Single ascending dose arm | CRMA-1001 Epigenetic gene silencing therapy delivered by intravenous (IV) infusion |
ExperimentalCRMA-1001 Part A, MAD Multiple ascending dose arm | CRMA-1001 Epigenetic gene silencing therapy delivered by intravenous (IV) infusion |
ExperimentalCRMA-1001 Part B Dose expansion | CRMA-1001 Epigenetic gene silencing therapy delivered by intravenous (IV) infusion |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Safety and tolerability of single and multiple doses of CRMA-1001 | Incidence and severity of treatment-emergent adverse events | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Long-term safety of single and multiple doses of CRMA-1001 | Incidence and severity of treatment emergent adverse events | 60 Months |
Pharmacokinetics of CRMA-1001 components (Cmax) | Maximum concentration (Cmax) in plasma | 6 Months |
Pharmacokinetics of CRMA-1001 components (Tmax) | Time of maximum concentration (Tmax) in plasma | 6 Months |
Pharmacokinetics of CRMA-1001 components (terminal clearance rate) | Clearance rate in terminal clearance phase (CL) in plasma | 6 Months |
Pharmacokinetics of CRMA-1001 components (Vd) | Volume of distribution (Vd) in plasma | 6 Months |
To evaluate the immunogenicity of CRMA-1001 | Incidence and characterization of anti-drug antibodies | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg) | Change from baseline in HBsAg | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs) | Change from baseline in anti-HBs antibody titier | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA) | Change from baseline in HBV DNA | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg) | Change from baseline in HBeAg | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe) | Change from baseline in anti-HBe antibody titer | 6 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg) | Change from baseline in HBsAg | 60 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs) | Change from baseline in anti-HBs antibody titer | 60 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA) | Change from baseline in HBV DNA | 60 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg) | Change from baseline in HBeAg | 60 Months |
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe) | Change from baseline in anti-HBe antibody titer | 60 Months |
To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001 | Proportion of participants able to discontinue antiviral therapy | 60 Months |
To evaluate the effect of CRMA-1001 on the incidence of functional cure | Incidence of functional cure | 60 Months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
- Other protocol-defined inclusion/exclusion criteria may apply
nChroma BioStudy Central Contact
Contact: nChroma Bio, (617) 915 6203, [email protected]
2 Study Locations in 2 Countries
New Zealand Clinical Research, Auckland, New Zealand
Edward Gane, Contact
Recruiting
Queen Mary Hospital, The University of Hong Kong, Hong Kong, 999077, Hong Kong
Man Fung Yuen, Contact
Recruiting