MedTrace Logo

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

NCT02414594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Akcea Therapeutics

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414594 on ClinicalTrials.gov