NCT03365947

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Typical duration for phase_1

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2024

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

December 4, 2017

Results QC Date

April 11, 2024

Last Update Submit

October 7, 2025

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    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)

    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)

    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)

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

  • +5 more secondary outcomes

Study Arms (19)

ARO-HBV 35 mg

EXPERIMENTAL

Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers

Drug: ARO-HBV

ARO-HBV 100 mg

EXPERIMENTAL

Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers

Drug: ARO-HBV

ARO-HBV 200 mg

EXPERIMENTAL

Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers

Drug: ARO-HBV

ARO-HBV 300 mg

EXPERIMENTAL

Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers

Drug: ARO-HBV

ARO-HBV 400 mg

EXPERIMENTAL

Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers

Drug: ARO-HBV

Placebo

PLACEBO COMPARATOR

Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers

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

Drug: ARO-HBV

ARO-HBV 50 mg Q28D

EXPERIMENTAL

ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B

Drug: ARO-HBV

ARO-HBV 100 mg Q28D

EXPERIMENTAL

ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B

Drug: ARO-HBV

ARO-HBV 200 mg Q28D

EXPERIMENTAL

ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B

Drug: ARO-HBV

ARO-HBV 300 mg Q28D

EXPERIMENTAL

ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B

Drug: ARO-HBV

ARO-HBV 400 mg Q28D

EXPERIMENTAL

ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B

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

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

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

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

Drug: ARO-HBV

ARO-HBV 200 mg, Q7D

EXPERIMENTAL

ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B

Drug: ARO-HBV

ARO-HBV 300 mg, Q7D

EXPERIMENTAL

ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B

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

Drug: ARO-HBVDrug: JNJ-56136379

Interventions

ARO-HBVDRUG

sc injection

ARO-HBV 100 mgARO-HBV 100 mg Q14DARO-HBV 100 mg Q28DARO-HBV 100 mg Q7DARO-HBV 200 mgARO-HBV 200 mg Q28DARO-HBV 200 mg Q28D + JNJ-56136379 250 mgARO-HBV 200 mg, Q7DARO-HBV 25 mg, Q28DARO-HBV 300 mgARO-HBV 300 mg Q28DARO-HBV 300 mg, Q28D, HBeAg+/ NUCARO-HBV 300 mg, Q28D, HBeAg+/ Trt NaïveARO-HBV 300 mg, Q7DARO-HBV 35 mgARO-HBV 400 mgARO-HBV 400 mg Q28DARO-HBV 50 mg Q28D
Sterile Normal Saline (0.9% NaCl)OTHER

sc injection

Placebo
JNJ-56136379DRUG

oral tablets

ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site 5

Camperdown, New South Wales, 2050, Australia

Location

Research Site 4

Clayton, Victoria, 3168, Australia

Location

Research Site 3

Melbourne, Victoria, 3065, Australia

Location

Research Site 6

Nedlands, Western Australia, 6009, Australia

Location

Research Site 7

Hong Kong, Hong Kong

Location

Research Site 1

Grafton, Auckland, 1010, New Zealand

Location

Research Site 2

Papatoetoe, Auckland, 2025, New Zealand

Location

Related Publications (2)

  • 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.

    PMID: 35870702RESULT

  • 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.

    PMID: 35695169DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

JNJ-56136379

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Chief Operating Officer
Organization
Arrowhead Pharmaceuticals, Inc.
info@arrowheadpharma.com
626-304-3400

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

March 27, 2018

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

October 22, 2025

Results First Posted

June 4, 2024

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)HK(1)NZ(2)