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

Phase 1

Completed

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: ARO-HSD Injection; Drug: sterile normal saline (0.9% NaCl)

• Registration Number: NCT04202354
• Lead Sponsor: Arrowhead Pharmaceuticals

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 available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Start: 2020-03-03
• Primary Completion: 2021-09-03
• Study Completion: 2021-11-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARO-HSD	ARO-HSD Injection	-
Placebo	sterile normal saline (0.9% NaCl)	-

Primary Outcome Measures

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

Name	Time	Method
PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)	Up through Day 29 after a single dose
PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)	Up through Day 29 after a single dose
PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)	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)	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)	Up through Day 29 after a single dose

Trial Locations

Locations (1)

Auckland Clinical Studies; 🇳🇿 Grafton, Auckland, New Zealand