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

nChroma Bio

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Hepaititis B

Treatments: Genetic: CRMA-1001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07200193

CRMA-1001-101

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

CRMA-1001 Part A, SAD

Experimental group

Description:

Single ascending dose arm

Treatment:

Genetic: CRMA-1001

CRMA-1001 Part A, MAD

Experimental group

Description:

Multiple ascending dose arm

Treatment:

Genetic: CRMA-1001

CRMA-1001 Part B

Experimental group

Description:

Dose expansion

Treatment:

Genetic: CRMA-1001