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NCT00339872 Clinical Trial

Study Evaluating IMA-638 in Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00339872
Other study ID # 3174K1-100
Secondary ID
Status Completed
Phase Phase 1
First received June 20, 2006
Last updated December 3, 2007
Start date February 2006
Est. completion date April 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• IMA-638

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary Drug levels in the blood and associated biomarkers will be evaluated.
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