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

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?

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