Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00447681

Purpose

This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.

Condition	Intervention	Phase
Healthy	Drug: ILV-094	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

Estimated Enrollment:	56
Study Start Date:	December 2006
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447681

Locations

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3199K1-100
Study First Received:	March 13, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00447681
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009