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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ILV-094

Drug

Primary outcomes

To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

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, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects

Important dates

Study start: 2006
Study completion: 2007
First posted: Mar 15, 2007
Registry last updated: Dec 13, 2007

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