Last updated on March 2019

A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product

Brief description of study

The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.

Detailed Study Description

This is a study comprising of 4 cohorts (cohorts 1 to 4) of 6 healthy subjects in each cohort (4 in each ASP5354 cohort and 2 in each placebo cohort). If the data from cohorts 1 to 3 are sufficient to characterize safety, tolerability and pharmacokinetics and the assessed doses reach the expected urine ASP5354 concentration, the study may be ended without running the fourth cohort.

Clinical Study Identifier: NCT03698305

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Covance CRU, Daytona Beach

Daytona Beach, FL United States
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Recruitment Status: Open

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