NCT00340327

Brief Summary

The purpose of this study is to evaluate the safety and drug levels for single, ascending doses of IMA-638 in healthy Japanese subjects.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

June 16, 2006

Last Update Submit

December 3, 2007

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety will be measured by evaluating physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.

Secondary Outcomes (1)

  • Drug levels and associated biomarkers will be evaluated.

Interventions

IMA-638DRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First generation healthy Japanese men and women of non-childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

anrukinzumab

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
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 21, 2006

Study Start

June 1, 2006

Study Completion

July 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

US(1)