Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)

A Phase 1/2a Single Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-HBV in Normal Adult Volunteers and Multiple Escalating Doses Evaluating Safety, Tolerability and Pharmacodynamic Effects in HBV Patients

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).

Inclusion Criteria for Parts A & B:

• Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception.
• Willing to provide written informed consent and comply with study requirements

Additional Inclusion Criteria for Part B:

• Diagnosis of chronic HBV infection
• Hepatitis B surface antigen (HbsAg) at screening > or = 50 IU/mL
• Liver Elastography score < or = 10.5

Exclusion Criteria:

• Clinically significant health concerns (with the exception of HBV for Patients in Part B)
• Abnormal for any clinical safety laboratory result considered clinically significant
• Regular use of alcohol within 1 month prior to screening
• Recent use of illicit drugs
• Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

NOTE: additional inclusion/exclusion criteria may apply, per protocol