A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
Recruiting
Phase 1
Phase 2
Interventional Study
Chronic Hepaititis B
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 66 (estimated)
- Sponsor
- nChroma Bio · Industry
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About This Trial
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 deli…
Trial Locations
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Eligibility Criteria
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 t…
Contacts