A Phase 1/2 interventional study of CRMA-1001 in Chronic Hepaititis B, sponsored by nChroma Bio. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by nChroma Bio · Phase 1/2, Interventional, and Treatment
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 66 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →This is the only study on the registry with nChroma Bio as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ascending dose arm
Genetic: CRMA-1001
Multiple ascending dose arm
Genetic: CRMA-1001
Dose expansion
Genetic: CRMA-1001
Epigenetic gene silencing therapy delivered by intravenous (IV) infusion
Safety and tolerability of single and multiple doses of CRMA-1001
Incidence and severity of treatment-emergent adverse events
Time frame: 6 months
Long-term safety of single and multiple doses of CRMA-1001
Incidence and severity of treatment emergent adverse events
Time frame: 60 Months
Pharmacokinetics of CRMA-1001 components (Cmax)
Maximum concentration (Cmax) in plasma
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (Tmax)
Time of maximum concentration (Tmax) in plasma
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (terminal clearance rate)
Clearance rate in terminal clearance phase (CL) in plasma
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (Vd)
Volume of distribution (Vd) in plasma
Time frame: 6 Months
To evaluate the immunogenicity of CRMA-1001
Incidence and characterization of anti-drug antibodies
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Change from baseline in HBsAg
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Change from baseline in anti-HBs antibody titier
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Change from baseline in HBV DNA
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Change from baseline in HBeAg
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Change from baseline in anti-HBe antibody titer
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Change from baseline in HBsAg
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Change from baseline in anti-HBs antibody titer
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Change from baseline in HBV DNA
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Change from baseline in HBeAg
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Change from baseline in anti-HBe antibody titer
Time frame: 60 Months
To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001
Proportion of participants able to discontinue antiviral therapy
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on the incidence of functional cure
Incidence of functional cure
Time frame: 60 Months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2032, 84 months after the start.
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