NCT07200193

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: nChroma Bio · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepaititis B

Interventions

Type	Name	Description
GENETIC	CRMA-1001	Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Timeline

• Start date: 2025-12-22
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2025-09-30
• Last updated: 2026-01-29

Locations

2 sites across 2 countries: Hong Kong, New Zealand