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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRMA-1001 Part A, SAD | Experimental | Single ascending dose arm |
|
| CRMA-1001 Part A, MAD | Experimental | Multiple ascending dose arm |
|
| CRMA-1001 Part B | Experimental | Dose expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRMA-1001 | Genetic | Epigenetic gene silencing therapy delivered by intravenous (IV) infusion |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nChroma Bio | Contact | (617) 915 6203 | CRMA-1001-101-Study@nchromabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils De Leon | Recruiting | Lyon | 69002 | France |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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 |
| Queen Mary Hospital, The University of Hong Kong | Recruiting | Hong Kong | 999077 | Hong Kong |
|
| New Zealand Clinical Research | Recruiting | Auckland | New Zealand |
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| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
|
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |