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

December 2, 2021 updated by: Arrowhead Pharmaceuticals

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Auckland Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
calculated volume to match active treatment, by sc injection
Experimental: ARO-HSD
single or multiple doses of ARO-HSD by subcutaneous (sc) injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
single dose phase: Up to 113 (+/-2 days) post-dose; multiple dose phase: (Up to 196 (+/- 14 days) post-dose for patients with NASH

Secondary Outcome Measures

Outcome Measure
Time Frame
PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)
Time Frame: Up through Day 29 after a single dose
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
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
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
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
Up through Day 29 after a single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

September 3, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AROHSD1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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