Healthy
Conditions
Keywords
healthy subjects
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.
Interventions
DRUGIMA-638
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* First generation healthy Japanese men and women of non-childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be measured by evaluating physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory test results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug levels and associated biomarkers will be evaluated. | — |
Countries
United States
Outcome results
None listed