NCT07200193

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
81mo left

Started Dec 2025

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Dec 2025Dec 2032

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

September 22, 2025

Last Update Submit

January 27, 2026

Conditions

Chronic Hepaititis B

Keywords

CHBChronic hepatitis BChronic HBVChronic Hep BChronic hepatitisHBV

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single and multiple doses of CRMA-1001

    Incidence and severity of treatment-emergent adverse events

    6 months

Secondary Outcomes (18)

  • Long-term safety of single and multiple doses of CRMA-1001

    60 Months

  • Pharmacokinetics of CRMA-1001 components (Cmax)

    6 Months

  • Pharmacokinetics of CRMA-1001 components (Tmax)

    6 Months

  • Pharmacokinetics of CRMA-1001 components (terminal clearance rate)

    6 Months

  • Pharmacokinetics of CRMA-1001 components (Vd)

    6 Months

  • +13 more secondary outcomes

Study Arms (3)

CRMA-1001 Part A, SAD

EXPERIMENTAL

Single ascending dose arm

Genetic: CRMA-1001

CRMA-1001 Part A, MAD

EXPERIMENTAL

Multiple ascending dose arm

Genetic: CRMA-1001

CRMA-1001 Part B

EXPERIMENTAL

Dose expansion

Genetic: CRMA-1001

Interventions

CRMA-1001GENETIC

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

CRMA-1001 Part A, MADCRMA-1001 Part A, SADCRMA-1001 Part B

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Significant hepatic fibrosis or cirrhosis
  • Current or prior liver disease other than HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, 999077, Hong Kong

RECRUITING

New Zealand Clinical Research

Auckland, New Zealand

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

nChroma Bio

CONTACT

(617) 915 6203CRMA-1001-101-Study@nchromabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)NZ(1)