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

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ClinicalTrials.gov Identifier: NCT03365947
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: ARO-HBV Injection Other: Sterile Normal Saline (0.9% NaCl) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARO-HBV Injection Drug: ARO-HBV Injection
Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection

Placebo Comparator: Placebo Other: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 203 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  3. 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 ]
  4. 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 ]
  5. PK of ARO-HBV: Terminal Elimination Half-Life (t½) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  6. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365947


Contacts
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Contact: James Hamilton, MD 626-304-3400 jhamilton@arrowheadpharma.com

Locations
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Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Susan Hoy    + 61295157383    susan.hoy@health.nsw.gov.au   
Principal Investigator: Simone Strasser, MD         
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact: Sherryne Warner    + 61395943081    sherryne.warner@monash.edu   
Principal Investigator: William Sievert, MD         
St. Vincent's Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Eleanor Cropp    +61392883594    Eleanor.cropp@svha.org.au   
Principal Investigator: Alexander Thompson, MD         
Australia, Western Australia
Linear Research Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Shashi Aggarwal    + 61432605618    saggarwal@linear.org.au   
Principal Investigator: Wendy Cheng, MD         
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ringo Wu    + 85222553579    rchwu@hku.hk   
Principal Investigator: Man-fung Yuen, MD         
New Zealand
Auckland Clinical Studies Limited Recruiting
Grafton, Auckland, New Zealand, 1010
Contact: Christian Schwabe, MD    +64-9-3733474    Christian@clinicalstudies.co.nz   
Principal Investigator: Edward Gane, MD         
Middlemore Clinical Trials Recruiting
Papatoetoe, Auckland, New Zealand, 2025
Contact: Amy Cryer    +64 (0)9 276 0044 ext 2170    Amy.Cryer@mmclintrials.nz   
Principal Investigator: Tien Huey Lim, MD         
Sponsors and Collaborators
Arrowhead Pharmaceuticals

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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03365947     History of Changes
Other Study ID Numbers: AROHBV1001
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections