NCT00734240

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

Double Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 353512 Administered Intravenously and Subcutaneously to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be a Phase 1, double blind, placebo-controlled, dose-escalation study conducted at a single center to 1)evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, 2)evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, and 3)evaluate the pharmacodynamics of ISIS 353512 in lowering constitutive levels of c-reactive proteins in healthy volunteers.

Conditions

• Inflammatory Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2008-08-14
• Last updated: 2010-07-29

Locations

1 site across 1 country: Canada