Study Evaluating Single Ascending Doses Of ILS-920

Phase 1

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: ILS-920

• Registration Number: NCT00827190
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Study Start: 2009-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Men or women of nonchildbearing potential
• Aged 18 to 50 years inclusive at screening.

Exclusion Criteria

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• History of drug abuse within 1 year before study day 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ILS-920	ILS-920

Primary Outcome Measures

Name	Time	Method
Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.	48 hours after study drug administration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.	48 hours after study drug administration