NCT04878471

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants

A Phase 1 Single Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.

Detailed description

This study is comprised of 3 parts. Part 1 and Part 2 will be conducted in a parallel manner while Part 3 will be conducted subsequentially. Participants will be residential for a period of 3 days/2 nights. Participants will be discharged from the clinical unit on day 2 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Pudexacianinium chloride	Intravenous
DRUG	Placebo	Intravenous

Timeline

• Start date: 2021-06-02
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2021-05-07
• Last updated: 2024-10-16

Locations

1 site across 1 country: Japan