Trials / Completed
CompletedNCT03365947
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Arrowhead Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARO-HBV | sc injection |
| OTHER | Sterile Normal Saline (0.9% NaCl) | sc injection |
| DRUG | JNJ-56136379 | oral tablets |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2020-04-23
- Completion
- 2020-04-23
- First posted
- 2017-12-08
- Last updated
- 2025-10-22
- Results posted
- 2024-06-04
Locations
7 sites across 3 countries: Australia, Hong Kong, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03365947. Inclusion in this directory is not an endorsement.