Study Complete
Sponsor ID
20140322
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Study Details
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
Protocol Summary
Primary Outcome Measures
Subject incidences of treatment-emergent adverse events.
Timeframe: Up to 105 days
Clinically significant changes in physical examinations.
Timeframe: Up to 105 days
Clinically significant changes in vital signs.
Timeframe: Up to 105 days
Clinically significant changes in laboratory safety tests.
Timeframe: Up to 105 days
Clinically significant changes in electrocardiograms (ECGs).
Timeframe: Up to 105 days
Secondary Outcome Measures
PK parameter of maximum observed concentration [Cmax].
Timeframe: Up to 105 days
PK parameter of time at Cmax [tmax].
Timeframe: Up to 105 days
PK parameter of area under the concentration-time curve [AUC].
Timeframe: Up tp 105 days
Peripheral Blood Receptor Occupancy Assessments.
Timeframe: Up to 105 days
Change in lymphocyte subset counts.
Timeframe: Up to 105 days
Anti-AMG 570 binding antibodies.
Timeframe: Up to 105 days
Locations
Location
Research Site
Evansville, IN, United States, 47710
Status
Completed
Location
Research Site
Madison, WI, United States, 53704
Status
Completed
Location
Research Site
Overland Park, KS, United States, 66212
Status
Completed