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

Primary Purpose

Non-alcoholic Steatohepatitis

Status

Completed

Phase

Phase 1

Locations

New Zealand

Study Type

Interventional

Intervention

ARO-HSD Injection

sterile normal saline (0.9% NaCl)

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis

Eligibility Criteria

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

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

Sites / Locations

Auckland Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARO-HSD

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)

PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)

PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)

PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)

PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)

Full Information

NCT ID

NCT04202354

First Posted

December 16, 2019

Last Updated

December 2, 2021

Sponsor

Arrowhead Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04202354

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

March 3, 2020 (Actual)

Primary Completion Date

September 3, 2021 (Actual)

Study Completion Date

November 23, 2021 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Non-alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARO-HSD

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ARO-HSD Injection

Intervention Description

single or multiple doses of ARO-HSD by subcutaneous (sc) injections

Intervention Type

Drug

Intervention Name(s)

sterile normal saline (0.9% NaCl)

Intervention Description

calculated volume to match active treatment, by sc injection

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)

Time Frame