Study Evaluating Single Ascending Doses Of ILS-920

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ILS-920

Drug

Primary outcomes

Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.

Time frame: 48 hours after study drug administration

Secondary outcomes

Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.

Time frame: 48 hours after study drug administration

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ILS-920 Administered Intravenously To Healthy Adult Subjects

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 22, 2009
Registry last updated: Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed