Skip to main content
OpenTrials
Completed

NCT Number: NCT03365947

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site 5, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARO-HBV

Drug

sc injection

Sterile Normal Saline (0.9% NaCl)

Other

sc injection

JNJ-56136379

Drug

oral tablets

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment

    Time frame: NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)

    An adverse event (AE) is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. Assessment of causality utilized 3 possible categories: not related, possibly related and probably related.

Secondary outcomes

  1. Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  2. Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  3. Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose

  4. Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  5. Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  6. Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  7. Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose

  8. Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  9. Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax

    Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

  10. Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV

    Time frame: Part B (multiple-ascending dose [MAD] phase) only: up to 113 days

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2017
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.