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

Dyslipidemias Clinical Trial

Official title:

A Phase 1 Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-ANG3 in Adult Healthy Volunteers and in Dyslipidemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747224
• Other study ID #: AROANG1001
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2019
• Est. completion date: May 17, 2021

Study information

• Verified date: September 2021
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 17, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Hypertriglyceridemia

Intervention

Drug:
• ARO-ANG3
single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections
• sterile normal saline (0.9% NaCl)
calculated volume to match active treatment

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Linear Clinical Research	Nedlands
New Zealand	Lipid & Diabetes Research Group	Christchurch
New Zealand	Auckland Clinical Studies Limited	Grafton	Auckland
New Zealand	Middlemore Hospital	Papatoetoe	Aukland

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment		Up to 113 (+/- 3 days) post-dose
Secondary	Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)		Single dose phase: Up to 48 hours post-dose
Secondary	PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)		Single dose phase: Up to 48 hours post-dose
Secondary	PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)		Single dose phase: Up to 48 hours post-dose
Secondary	PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)		Single dose phase: Up to 48 hours post-dose
Secondary	PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)		Single dose phase: Up to 48 hours post-dose
Secondary	Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline		Baseline, Up to Day 113 (+/- 3 days)