Hepatitis BPhase 1/2NCT03365947

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

A Phase 1/2 study testing ARO-HBV, Sterile Normal Saline (0.9% NaCl) and JNJ-56136379 in people with Hepatitis B, run by Arrowhead Pharmaceuticals at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: ARO-HBV, Sterile Normal Saline (0.9% NaCl) and JNJ-56136379
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 7 sitesin 3 countries
Study dates: 27 Mar 2018to 23 Apr 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Australia4 sites

Research Site 5
Camperdown, New South Wales, 2050
Research Site 4
Clayton, Victoria, 3168
Research Site 3
Melbourne, Victoria, 3065
Research Site 6
Nedlands, Western Australia, 6009

Other trials in Australia

New Zealand2 sites

Research Site 1
Grafton, Auckland, 1010
Research Site 2
Papatoetoe, Auckland, 2025

Other trials in New Zealand

Hong Kong1 site

Research Site 7
Hong Kong

Other trials in Hong Kong

About this study

Official 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

Conditions: Hepatitis B
Being tested: ARO-HBV, Sterile Normal Saline (0.9% NaCl), JNJ-56136379
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARO-HBVDrug
sc injection
Sterile Normal Saline (0.9% NaCl)Other
sc injection
JNJ-56136379Drug
oral tablets

Study groups in NCT03365947
Study group	Role	What they receive
ARO-HBV 35 mg	Experimental	Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers Receives: Drug: ARO-HBV
ARO-HBV 100 mg	Experimental	Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers Receives: Drug: ARO-HBV
ARO-HBV 200 mg	Experimental	Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers Receives: Drug: ARO-HBV
ARO-HBV 300 mg	Experimental	Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers Receives: Drug: ARO-HBV
ARO-HBV 400 mg	Experimental	Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers Receives: Drug: ARO-HBV
Placebo	Placebo comparator	Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers Receives: Other: Sterile Normal Saline (0.9% NaCl)
ARO-HBV 25 mg, Q28D	Experimental	ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 50 mg Q28D	Experimental	ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 100 mg Q28D	Experimental	ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 200 mg Q28D	Experimental	ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 300 mg Q28D	Experimental	ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 400 mg Q28D	Experimental	ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 100 mg Q14D	Experimental	ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 100 mg Q7D	Experimental	ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve	Experimental	ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 300 mg, Q28D, HBeAg+/ NUC	Experimental	ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 200 mg, Q7D	Experimental	ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 300 mg, Q7D	Experimental	ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B Receives: Drug: ARO-HBV
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg	Experimental	ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B Receives: Drug: ARO-HBV; Drug: JNJ-56136379

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
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.
Measured: NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)

Secondary outcomes (10)

Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Part B (multiple-ascending dose [MAD] phase) only: up to 113 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201823 Apr 2020

First posted8 Dec 2017
Study start27 Mar 2018
Primary completion23 Apr 2020
Study completion23 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis BStudies of the same condition, open and under way.
More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03365947
Sponsor's protocol ID: AROHBV1001
Status last verified: Oct 2025
First submitted: 4 Dec 2017
Last updated: 22 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20.
PubMed 35870702
Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856.
PubMed 35695169

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03365947
Acronym / sponsor ID: AROHBV1001
Conditions: Hepatitis B
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 27 Mar 2018 (actual)
Primary completion: 23 Apr 2020 (actual)
Study completion: 23 Apr 2020 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 4 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 19

Arm	Type	Receives
ARO-HBV 35 mg	Experimental	Drug: ARO-HBVSingle dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
ARO-HBV 100 mg	Experimental	Drug: ARO-HBVSingle dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
ARO-HBV 200 mg	Experimental	Drug: ARO-HBVSingle dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
ARO-HBV 300 mg	Experimental	Drug: ARO-HBVSingle dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
ARO-HBV 400 mg	Experimental	Drug: ARO-HBVSingle dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
Placebo	Placebo comparator	Other: Sterile Normal Saline (0.9% NaCl)Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
ARO-HBV 25 mg, Q28D	Experimental	Drug: ARO-HBVARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
ARO-HBV 50 mg Q28D	Experimental	Drug: ARO-HBVARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV 100 mg Q28D	Experimental	Drug: ARO-HBVARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV 200 mg Q28D	Experimental	Drug: ARO-HBVARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV 300 mg Q28D	Experimental	Drug: ARO-HBVARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV 400 mg Q28D	Experimental	Drug: ARO-HBVARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV 100 mg Q14D	Experimental	Drug: ARO-HBVARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
ARO-HBV 100 mg Q7D	Experimental	Drug: ARO-HBVARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve	Experimental	Drug: ARO-HBVARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
ARO-HBV 300 mg, Q28D, HBeAg+/ NUC	Experimental	Drug: ARO-HBVARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
ARO-HBV 200 mg, Q7D	Experimental	Drug: ARO-HBVARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
ARO-HBV 300 mg, Q7D	Experimental	Drug: ARO-HBVARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg	Experimental	Drug: ARO-HBV, Drug: JNJ-56136379ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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
Diagnosis of chronic HBV infection
Hepatitis B surface antigen (HbsAg) at screening > or = 50 IU/mL
Liver Elastography score < or = 10.5

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARO-HBVsc injection	Drug	ARO-HBV 100 mg, ARO-HBV 100 mg Q14D, ARO-HBV 100 mg Q28D, ARO-HBV 100 mg Q7D, ARO-HBV 200 mg, ARO-HBV 200 mg Q28D, ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg, ARO-HBV 200 mg, Q7D, ARO-HBV 25 mg, Q28D, ARO-HBV 300 mg, ARO-HBV 300 mg Q28D, ARO-HBV 300 mg, Q28D, HBeAg+/ NUC, ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve, ARO-HBV 300 mg, Q7D, ARO-HBV 35 mg, ARO-HBV 400 mg, ARO-HBV 400 mg Q28D, ARO-HBV 50 mg Q28D
Sterile Normal Saline (0.9% NaCl)sc injection	Other	Placebo
JNJ-56136379oral tablets	Drug	ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg

Primary outcome

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.

10 secondary outcomes

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
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
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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 4 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARO-HBV 35 mg	4	4
ARO-HBV 100 mg	4	4
ARO-HBV 200 mg	4	4
ARO-HBV 300 mg	4	4
ARO-HBV 400 mg	4	4
Placebo	10	9
ARO-HBV 25 mg, Q28D	8	8
ARO-HBV 50 mg Q28D	8	8
ARO-HBV 100 mg Q28D	8	8
ARO-HBV 200 mg Q28D	8	8
ARO-HBV 300 mg Q28D	8	8
ARO-HBV 400 mg Q28D	8	8
ARO-HBV 100 mg Q14D	4	4
ARO-HBV 100 mg Q7D	4	4
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve	4	4
ARO-HBV 300 mg, Q28D, HBeAg+/NUC	4	4
ARO-HBV 200 mg, Q7D	4	4
ARO-HBV 300 mg, Q7D	4	4
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg	12	12

Primary outcome: 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). Count of participants. Unit: Participants

Measure	ARO-HBV 35 mg n = 4	ARO-HBV 100 mg n = 4	ARO-HBV 200 mg n = 4	ARO-HBV 300 mg n = 4	ARO-HBV 400 mg n = 4	Placebo n = 10	ARO-HBV 25 mg Q28D n = 8	ARO-HBV 50 mg Q28D n = 8	ARO-HBV 100 mg Q28D n = 8	ARO-HBV 200 mg Q28D n = 8	ARO-HBV 300 mg Q28D n = 8	ARO-HBV 400 mg Q28D n = 8	ARO-HBV 100 mg Q14D n = 4	ARO-HBV 100 mg Q7D n = 4	ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve n = 4	ARO-HBV 300 mg, Q28D, HBeAg+/NUC n = 4	ARO-HBV 200 mg, Q7D n = 4	ARO-HBV 300 mg, Q7D n = 4	ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg n = 12
Possibly Related TEAE	1	1	1	1	1	5	2	2	1	1	5	3	0	2	2	0	0	0	0
Probably Related TEAE	0	0	0	1	0	0	1	0	0	1	2	2	0	0	2	1	0	2	0

Population analysed: Safety Population: all participants who received at least 1 dose of study drug.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARO-HBV 35 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
ARO-HBV 100 mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
ARO-HBV 200 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
ARO-HBV 300 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
ARO-HBV 400 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Placebo	0 of 10 (0%)	8 of 10 (80%)	0 of 10
ARO-HBV 25 mg Q28D	0 of 8 (0%)	6 of 8 (75%)	0 of 8
ARO-HBV 50 mg Q28D	0 of 8 (0%)	6 of 8 (75%)	0 of 8
ARO-HBV 100 mg Q28D	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
ARO-HBV 200 mg Q28D	0 of 8 (0%)	4 of 8 (50%)	0 of 8
ARO-HBV 300 mg Q28D	0 of 8 (0%)	6 of 8 (75%)	0 of 8
ARO-HBV 400 mg Q28D	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8
ARO-HBV 100 mg Q14D	0 of 4 (0%)	3 of 4 (75%)	0 of 4
ARO-HBV 100 mg Q7D	0 of 4 (0%)	4 of 4 (100%)	0 of 4
ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve	0 of 4 (0%)	3 of 4 (75%)	0 of 4
ARO-HBV 300 mg, Q28D, HBeAg+/NUC	0 of 4 (0%)	2 of 4 (50%)	0 of 4
ARO-HBV 200 mg, Q7D	0 of 4 (0%)	4 of 4 (100%)	0 of 4
ARO-HBV 300 mg, Q7D	1 of 4 (25%)	3 of 4 (75%)	0 of 4
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg	1 of 12 (8.3%)	3 of 12 (25%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35870702Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20.
Derived from this study: PubMed 35695169Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARO-HBV, Sterile Normal Saline (0.9% NaCl) and JNJ-56136379 in people with Hepatitis B, run by Arrowhead Pharmaceuticals at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, New Zealand, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03365947, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.