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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04202354




Registration number
NCT04202354
Ethics application status
Date submitted
16/12/2019
Date registered
17/12/2019
Date last updated
12/03/2020

Titles & IDs
Public title
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
Scientific title
A Phase 1 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
Secondary ID [1] 0 0
AROHSD1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-HSD Injection
Treatment: Drugs - sterile normal saline (0.9% NaCl)

Experimental: ARO-HSD -

Placebo Comparator: Placebo -


Treatment: Drugs: ARO-HSD Injection
single or multiple doses of ARO-HSD by subcutaneous (sc) injections

Treatment: Drugs: sterile normal saline (0.9% NaCl)
calculated volume to match active treatment, by sc injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Timepoint [1] 0 0
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 [1] 0 0
PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Up through Day 29 after a single dose
Secondary outcome [2] 0 0
PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)
Timepoint [2] 0 0
Up through Day 29 after a single dose
Secondary outcome [3] 0 0
PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)
Timepoint [3] 0 0
Up through Day 29 after a single dose
Secondary outcome [4] 0 0
PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Timepoint [4] 0 0
Up through Day 29 after a single dose
Secondary outcome [5] 0 0
PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Timepoint [5] 0 0
Up through Day 29 after a single dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04202354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
626-304-3400
Fax 0 0
Email 0 0
clinicaltrials@arrowheadpharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04202354