Absolute Bioavailability of Reslizumab in Healthy Subjects
A Randomized, Open-Label, Parallel-Group, Single-Dose Study to Characterize the Absolute Bioavailability of Reslizumab (220 mg) Following Subcutaneous Administration to Healthy Subjects
A Randomized, Open-Label, Parallel-Group, Single-Dose Study to Characterize the Absolute Bioavailability of Reslizumab (220 mg) Following Subcutaneous Administration to Healthy Subjects
Sponsor study identifier
interventional
75
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
March 2014
Actual (reported)The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 15, 2013
Actual (reported)November 21, 2013
Actual (reported)December 2013
Actual (reported)March 2014
Actual (reported)Absolute bioavailability
Absolute bioavailability calculated as (AUC0-∞)sc/(AUC0-∞)
From baseline to Day 140
Maximum observed serum drug concentration (Cmax)
From baseline to Day 140
Time to maximum observed serum drug concentration (tmax)
From baseline to Day 140
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
From baseline to Day 140
Percentage extrapolation
From baseline to Day 140
Apparent serum terminal elimination rate constant (λz)
From baseline to Day 140
Reslizumab 220-mg administered Intravenously (IV)
Reslizumab 220-mg administered Subcutaneously (SC)
Teva Investigational Site 10567
Anaheim, California, United States
75 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2013
First Posted
November 21, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
March 31, 2014
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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