NCT02709850

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia

A Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ISIS 703802, Targeting ANGPTL3, Administered Subcutaneously to Healthy Volunteers With Elevated Triglycerides and Subjects With Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.

Conditions

• Hypertriglyceridemia
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	IONIS ANGPTL3-LRx
DRUG	Placebo	0.9%NaCl, water, riboflavin

Timeline

• Start date: 2015-11-30
• Primary completion: 2017-04-12
• Completion: 2017-06-26
• First posted: 2016-03-16
• Last updated: 2020-11-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study