Chronic Hepaititis B
Conditions
Keywords
CHB, Chronic hepatitis B, Chronic HBV, Chronic Hep B, Chronic hepatitis, HBV
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 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.
Interventions
GENETICCRMA-1001
Epigenetic gene silencing therapy delivered by intravenous (IV) infusion
Sponsors
nChroma Bio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single and multiple doses of CRMA-1001 | 6 months | Incidence and severity of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of single and multiple doses of CRMA-1001 | 60 Months | Incidence and severity of treatment emergent adverse events |
| Pharmacokinetics of CRMA-1001 components (Cmax) | 6 Months | Maximum concentration (Cmax) in plasma |
| Pharmacokinetics of CRMA-1001 components (Tmax) | 6 Months | Time of maximum concentration (Tmax) in plasma |
| Pharmacokinetics of CRMA-1001 components (terminal clearance rate) | 6 Months | Clearance rate in terminal clearance phase (CL) in plasma |
| Pharmacokinetics of CRMA-1001 components (Vd) | 6 Months | Volume of distribution (Vd) in plasma |
| To evaluate the immunogenicity of CRMA-1001 | 6 Months | Incidence and characterization of anti-drug antibodies |
| To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg) | 6 Months | Change from baseline in HBsAg |
| To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs) | 6 Months | Change from baseline in anti-HBs antibody titier |
| To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA) | 6 Months | Change from baseline in HBV DNA |
| To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg) | 6 Months | Change from baseline in HBeAg |
| To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe) | 6 Months | Change from baseline in anti-HBe antibody titer |
| To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001 | 60 Months | Proportion of participants able to discontinue antiviral therapy |
| To evaluate the effect of CRMA-1001 on the incidence of functional cure | 60 Months | Incidence of functional cure |
Countries
France, Hong Kong, New Zealand, United Kingdom
Contacts
CONTACTnChroma Bio
Outcome results
None listed