NCT00434746

Brief Summary

The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.

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 Jan 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

February 9, 2007

Last Update Submit

July 8, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • To provide safety, tolerability, PK and immunogenicity profiles

    1 year

Interventions

ILV-094DRUG

Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 20 to 45 years inclusive at screening.
  • Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight\>45.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
  • Healthy as determined by the investigator on the basis of screening evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ikebukuro, Tokyo, 171-0014, Japan

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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

JP(1)