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Trial record 1 of 1 for:    NCT03365947
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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

Tracking Information
First Submitted Date  ICMJE December 4, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE March 27, 2018
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 203 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Part A (single-ascending dose [SAD] phase): up to 90 days; Part B (multiple-ascending dose [MAD] phase): up to 203 days ]
Change History Complete list of historical versions of study NCT03365947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • 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 ]
  • PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  • 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 ]
  • 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 ]
  • PK of ARO-HBV: Terminal Elimination Half-Life (t½) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Pharmacokinetics (PK) of ARO-HBV: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  • PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  • 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 ]
  • 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 ]
  • PK of ARO-HBV: Terminal Elimination Half-Life (t½) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  • 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 (MAD phase) only: up to 113 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Drug: ARO-HBV Injection
    Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection
  • Other: Sterile Normal Saline (0.9% NaCl)
    Calculated volume to match active comparator
Study Arms  ICMJE
  • Active Comparator: ARO-HBV Injection
    Intervention: Drug: ARO-HBV Injection
  • Placebo Comparator: Placebo
    Intervention: Other: Sterile Normal Saline (0.9% NaCl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2019)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
60
Estimated Study Completion Date  ICMJE January 30, 2020
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: James Hamilton, MD 626-304-3400 jhamilton@arrowheadpharma.com
Listed Location Countries  ICMJE Australia,   Hong Kong,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03365947
Other Study ID Numbers  ICMJE AROHBV1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arrowhead Pharmaceuticals
Study Sponsor  ICMJE Arrowhead Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arrowhead Pharmaceuticals
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP