- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202354
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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