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

Healthy Subjects Clinical Trial

Official title:
A Double-blinded, Randomized, Controlled, Single Ascending Dose Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product

Clinical Trial Summary

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.

Clinical Trial Description

This is a study comprising of 5 cohorts (cohorts 1 to 5) 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 or fifth cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03698305
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 1
Start date October 25, 2018
Completion date May 20, 2019
View Details
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