Status:
COMPLETED
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03365947
Start Date
March 27 2018
End Date
April 23 2020
Last Update
October 22 2025
Active Locations (7)
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1
Research Site 5
Camperdown, New South Wales, Australia, 2050
2
Research Site 4
Clayton, Victoria, Australia, 3168
3
Research Site 3
Melbourne, Victoria, Australia, 3065
4
Research Site 6
Nedlands, Western Australia, Australia, 6009