NCT03698305

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP5354	Intravenous
DRUG	Placebo	Intravenous

Timeline

• Start date: 2018-10-25
• Primary completion: 2019-05-20
• Completion: 2019-05-20
• First posted: 2018-10-09
• Last updated: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study