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

NCT ID: NCT07200193

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepaititis B

Keywords

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CHB Chronic hepatitis B Chronic HBV Chronic Hep B Chronic hepatitis HBV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRMA-1001 Part A, SAD

Single ascending dose arm

Group Type EXPERIMENTAL

CRMA-1001

Intervention Type GENETIC

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

CRMA-1001 Part A, MAD

Multiple ascending dose arm

Group Type EXPERIMENTAL

CRMA-1001

Intervention Type GENETIC

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

CRMA-1001 Part B

Dose expansion

Group Type EXPERIMENTAL

CRMA-1001

Intervention Type GENETIC

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Interventions

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CRMA-1001

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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nChroma Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CRMA-1001-101

Identifier Type: -

Identifier Source: org_study_id