Clinical trial NCT04202354: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Arrowhead Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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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Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
timeFrame: 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 outcomes:
measure: PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)
timeFrame: Up through Day 29 after a single dose
measure: PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Up through Day 29 after a single dose
measure: PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)
timeFrame: Up through Day 29 after a single dose
measure: PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
timeFrame: Up through Day 29 after a single dose
measure: PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
timeFrame: Up through Day 29 after a single dose
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies
state: Auckland
Study officials:
References: