Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or … (NCT04202354) | Clinical Trial Compass
CompletedPhase 1/2
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
New Zealand50 participantsStarted 2020-03-03
Plain-language 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.
Who can participate
Age range19 Years – 65 Years
SexALL
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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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What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
Timeframe: From first dose of study drug through Day 113 (±5 days)