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Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH

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ClinicalTrials.gov Identifier: NCT04202354
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 17, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE March 3, 2020
Estimated Primary Completion Date November 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: single dose phase: Up to 113 (+/-2 days) post-dose; multiple dose phase: (Up to 196 (+/- 14 days) post-dose for patients with NASH ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax) [ Time Frame: Up through Day 29 after a single dose ]
  • PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up through Day 29 after a single dose ]
  • PK of ARO-HSD: Terminal Elimination Half-Life (t1/2) [ Time Frame: Up through Day 29 after a single dose ]
  • PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: Up through Day 29 after a single dose ]
  • PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) [ Time Frame: Up through Day 29 after a single dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
Official Title  ICMJE A Phase 1/2a Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-HSD in Normal Healthy Volunteers as Well as in Patients With NASH or Suspected NASH
Brief Summary The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-alcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: ARO-HSD Injection
    single or multiple doses of ARO-HSD by subcutaneous (sc) injections
  • Drug: sterile normal saline (0.9% NaCl)
    calculated volume to match active treatment, by sc injection
Study Arms  ICMJE
  • Experimental: ARO-HSD
    Intervention: Drug: ARO-HSD Injection
  • Placebo Comparator: Placebo
    Intervention: Drug: 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: July 29, 2020)
44
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)
74
Estimated Study Completion Date  ICMJE February 11, 2022
Estimated Primary Completion Date November 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements
  • On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
  • Normal electrocardiogram (ECG) at Screening
  • No abnormal finding of clinical relevance (other than NASH, suspected NASH in patients) at Screening that could adversely impact subject safety during the study or adversely impact study results.

Exclusion Criteria:

  • Clinically significant health concerns (other than NASH, suspected NASH in patients)
  • Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
  • Uncontrolled hypertension
  • Excessive use of alcohol within three months prior to Screening
  • Use of illicit drugs within 1 year prior to Screening, or positive urine drug screen at Screening
  • 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

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Medical Monitor 626-304-3400 clinicaltrials@arrowheadpharma.com
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04202354
Other Study ID Numbers  ICMJE AROHSD1001
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 March 2021

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