NCT00447681

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

March 13, 2007

Last Update Submit

December 11, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

Interventions

ILV-094DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Interventions

fezakinumab

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

December 1, 2006

Study Completion

November 1, 2007

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

US(1)