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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: March 13, 2007
Last updated: December 11, 2007
Last verified: December 2007

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
Drug: ILV-094
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
  • 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 identifier: NCT00447681

United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00447681     History of Changes
Other Study ID Numbers: 3199K1-100
Study First Received: March 13, 2007
Last Updated: December 11, 2007
Health Authority: United States: Food and Drug Administration processed this record on April 17, 2014