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

• Status: Completed
• Trial end date: 2020-04-23
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

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

• 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