Back to resultsStudy Evaluating IMA-638 in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMA-638
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring healthy subjects
Eligibility Criteria
Inclusion Criteria: Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted. Well controlled asthma, as exhibited by completion of asthma questionnaire. Otherwise healthy, except for asthma.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary Outcome Measures
Drug levels in the blood and associated biomarkers will be evaluated.
Full Information
NCT ID
NCT00339872
First Posted
June 20, 2006
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00339872
Brief Title
Study Evaluating IMA-638 in Asthma
Official Title
Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-638 Administered Subcutaneously and Intravenously to Subjects With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
healthy subjects
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IMA-638
Primary Outcome Measure Information:
Title
Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary Outcome Measure Information:
Title
Drug levels in the blood and associated biomarkers will be evaluated.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted.
Well controlled asthma, as exhibited by completion of asthma questionnaire.
Otherwise healthy, except for asthma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating IMA-638 in Asthma
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