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NCT Number: NCT07200193

A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B

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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Key information

Conditions

Chronic Hepaititis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospices Civils De Leon, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRMA-1001

Genetic

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Primary outcomes

  1. Safety and tolerability of single and multiple doses of CRMA-1001

    Time frame: 6 months

    Incidence and severity of treatment-emergent adverse events

Secondary outcomes

  1. Long-term safety of single and multiple doses of CRMA-1001

    Time frame: 60 Months

    Incidence and severity of treatment emergent adverse events

  2. Pharmacokinetics of CRMA-1001 components (Cmax)

    Time frame: 6 Months

    Maximum concentration (Cmax) in plasma

  3. Pharmacokinetics of CRMA-1001 components (Tmax)

    Time frame: 6 Months

    Time of maximum concentration (Tmax) in plasma

  4. Pharmacokinetics of CRMA-1001 components (terminal clearance rate)

    Time frame: 6 Months

    Clearance rate in terminal clearance phase (CL) in plasma

  5. Pharmacokinetics of CRMA-1001 components (Vd)

    Time frame: 6 Months

    Volume of distribution (Vd) in plasma

  6. To evaluate the immunogenicity of CRMA-1001

    Time frame: 6 Months

    Incidence and characterization of anti-drug antibodies

  7. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)

    Time frame: 6 Months

    Change from baseline in HBsAg

  8. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)

    Time frame: 6 Months

    Change from baseline in anti-HBs antibody titier

  9. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)

    Time frame: 6 Months

    Change from baseline in HBV DNA

  10. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)

    Time frame: 6 Months

    Change from baseline in HBeAg

  11. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)

    Time frame: 6 Months

    Change from baseline in anti-HBe antibody titer

  12. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)

    Time frame: 60 Months

    Change from baseline in HBsAg

  13. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)

    Time frame: 60 Months

    Change from baseline in anti-HBs antibody titer

  14. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)

    Time frame: 60 Months

    Change from baseline in HBV DNA

  15. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)

    Time frame: 60 Months

    Change from baseline in HBeAg

  16. To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)

    Time frame: 60 Months

    Change from baseline in anti-HBe antibody titer

  17. To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001

    Time frame: 60 Months

    Proportion of participants able to discontinue antiviral therapy

  18. To evaluate the effect of CRMA-1001 on the incidence of functional cure

    Time frame: 60 Months

    Incidence of functional cure

Study contacts

Contact information is provided by the study sponsor or research team.

nChroma Bio

CONTACT

[email protected]

(617) 915 6203

Sponsors and collaborators

Lead sponsor

nChroma Bio

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Sep 30, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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