Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients

• Status: Completed
• Trial end date: 2021-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

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

Exclusion Criteria:

• Clinically significant health concerns

• Regular use of alcohol within one month prior to Screening

• Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

• Recent use of illicit drugs

• Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)

NOTE: additional inclusion/exclusion criteria may apply, per protocol