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Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides

NCT02900027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-05-22

No results posted yet for this study

Summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.

Conditions

  • Elevated Triglycerides (TG)

Interventions

DRUG

APOC-III-L-Rx

Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection

DRUG

Placebo Comparator

Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Sponsors & Collaborators

  • Akcea Therapeutics

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor · BioPharma Services

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Canada

Study Locations

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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 NCT02900027 on ClinicalTrials.gov