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

Condition(s) studied

Investigational drug(s) / intervention(s)

CRMA-1001: Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Study 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.

Eligibility

Primary outcome measure(s)

• Safety and tolerability of single and multiple doses of CRMA-1001 — 6 months
  Incidence and severity of treatment-emergent adverse events

Trial sites (4)