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

Non-alcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202354
• Other study ID #: AROHSD1001
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: December 2021
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 23, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• ARO-HSD Injection
single or multiple doses of ARO-HSD by subcutaneous (sc) injections
• sterile normal saline (0.9% NaCl)
calculated volume to match active treatment, by sc injection

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies	Grafton	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)		Up through Day 29 after a single dose
Secondary	PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)		Up through Day 29 after a single dose
Secondary	PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)		Up through Day 29 after a single dose
Secondary	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
Secondary	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