At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 enrolled
Drug / intervention
ARO-HBV +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ARO-HBV, Sterile Normal Saline (0.9% NaCl), and 1 other intervention for Hepatitis B. Completed, enrolled 114 participants across 7 sites in 3 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesAustralia, Hong Kong, New Zealand
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartMar 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedDec 8, 2017
Enrollment StartMar 27, 2018
Primary CompletionApr 23, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.6 years ago
Interventions
ARO-HBVdrug
sc injection
Sterile Normal Saline (0.9% NaCl)other
sc injection
JNJ-56136379drug
oral tablets