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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ARO-HBV Injection
Sterile Normal Saline (0.9% NaCl)
Sponsored by
Arrowhead Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • 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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Monash Medical Centre
  • St. Vincent's Hospital
  • Linear Research
  • Queen Mary Hospital
  • Auckland Clinical Studies Limited
  • Middlemore Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ARO-HBV Injection

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment

Secondary Outcome Measures

Pharmacokinetics (PK) of ARO-HBV: Maximum Observed Plasma Concentration (Cmax)
PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax)
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
PK of ARO-HBV: Terminal Elimination Half-Life (t½)
Reduction of HBV Surface Antigen (HBsAg) from Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV

Full Information

First Posted
December 4, 2017
Last Updated
April 22, 2021
Sponsor
Arrowhead Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03365947
Brief Title
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrowhead Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARO-HBV Injection
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARO-HBV Injection
Intervention Description
Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection
Intervention Type
Other
Intervention Name(s)
Sterile Normal Saline (0.9% NaCl)
Intervention Description
Calculated volume to match active comparator
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment
Time Frame
Up to 203 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of ARO-HBV: Maximum Observed Plasma Concentration (Cmax)
Time Frame
Part A (single-ascending dose [SAD] phase) only: up to 48 hours post-dose
Title
PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax)
Time Frame
Part A (SAD phase) only: up to 48 hours post-dose
Title
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Time Frame
Part A (SAD phase) only: up to 48 hours post-dose
Title
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Time Frame
Part A (SAD phase) only: up to 48 hours post-dose
Title
PK of ARO-HBV: Terminal Elimination Half-Life (t½)
Time Frame
Part A (SAD phase) only: up to 48 hours post-dose
Title
Reduction of 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Linear Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Auckland Clinical Studies Limited
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35870702
Citation
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.
Results Reference
derived
PubMed Identifier
35695169
Citation
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.
Results Reference
derived

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

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