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Dose-escalating Safety Study in Subjects on Stable Statin Therapy

NCT00231569 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-08-03

No results posted yet for this study

Summary

The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.

Conditions

Interventions

DRUG

ISIS 301012 or Placebo

30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29

DRUG

ISIS 301012 or Placebo

100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29

DRUG

ISIS 301012 or Placebo

200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29

DRUG

ISIS 301012 or Placebo

300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29

DRUG

ISIS 301012 or Placebo

400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29

DRUG

ISIS 301012 or Placebo

200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

DRUG

ISIS 301012 or Placebo

300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Kastle Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-06-30
Completion
2007-12-31

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT00231569 on ClinicalTrials.gov