Study Evaluating IMA-638 in Asthma
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2006
Typical duration for phase_1 asthma
1 active site
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
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 20, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedDecember 5, 2007
December 1, 2007
June 20, 2006
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary Outcomes (1)
Drug levels in the blood and associated biomarkers will be evaluated.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Denver, Colorado, 80230, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
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 20, 2006
First Posted
June 21, 2006
Study Start
February 1, 2006
Study Completion
April 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12