Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512 from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the blood associated with inflammation.

Conditions

• Inflammatory Diseases

Interventions

DRUG

ISIS 353512

50 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

50 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

50 mg via SC injection, single dose

DRUG

ISIS 353512

50 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8

DRUG

ISIS 353512

100 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

200 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

100 mg via SC injection, single dose

DRUG

ISIS 353512

200 mg via SC injection, single-dose

DRUG

ISIS 353512

100 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

200 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

100 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

200 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo

DRUG

ISIS 353512

200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid

DRUG

ISIS 353512

2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8

Sponsors & Collaborators

• Anapharm

  collaborator INDUSTRY

• Ionis Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Richard Larouche, M.D. · Anapharm

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2010-02-28

Completion

2010-03-31

Countries

• Canada

Study Locations