NCT02414594

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)

A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 681257 Administered Subcutaneously to Healthy Volunteers With Elevated Lipoprotein(a)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.

Conditions

• Elevated Lipoprotein(a)

Interventions

Type	Name	Description
DRUG	IONIS-APO(a)-LRx	Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	Calculated volume to match active comparator

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-04-13
• Last updated: 2018-12-05

Locations

1 site across 1 country: Canada