- A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B — Recruiting • Phase I • Gastroenterology • NCT07200193.
- Drug being tested: CRMA-1001, a novel therapeutic agent undergoing Phase 1/2 evaluation for safety, tolerability, and efficacy in adults with chronic hepatitis B using single-dose, multiple-dose escalation, and dose expansion study designs.
- Patient eligibility overview: Adults with confirmed chronic hepatitis B infection; specific inclusion/exclusion criteria (such as disease severity, liver function, and prior treatment history) determine suitability for enrollment across ascending dose cohorts.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * Male/Female, weight 45-150 kg, age 18-64, inclusive * Diagnosed with Chronic Hepatitis B * On oral antiviral therapy * ALT and AST
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.