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

October 7, 2025 updated by: Arrowhead Pharmaceuticals

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Research Site 5
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Research Site 4
      • Melbourne, Victoria, Australia, 3065
        • Research Site 3
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Site 6
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site 7
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Research Site 1
      • Papatoetoe, Auckland, New Zealand, 2025
        • Research Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARO-HBV 35 mg
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 100 mg
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 200 mg
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 300 mg
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
Drug: ARO-HBV
sc injection
Placebo Comparator: Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
Other: Sterile Normal Saline (0.9% NaCl)
sc injection
Experimental: ARO-HBV 25 mg, Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve
ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 300 mg, Q28D, HBeAg+/ NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Experimental: ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
Drug: ARO-HBV
sc injection
Drug: JNJ-56136379
oral tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
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
Part B (multiple-ascending dose [MAD] phase) only: up to 113 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arrowhead Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AROHBV1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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