NCT02140125

A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male Subjects

Phase I Study of ASP2408 -Subcutaneous Single-dose, Placebo-controlled Study in Non-elderly Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.

Detailed description

This clinical study will be conducted as a double-blind, placebo-controlled, single ascending subcutaneous dose study. As shown in the table below, the study will be conducted using 3 cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects receiving ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects, who will be randomly assigned to either the ASP2408 group or the placebo group at the ratio of 3 to 1. Each subject will need to be hospitalized until Day 8 (start date of study drug administration will be regarded as Day 1) and will be observed until Day 90. The investigator or subinvestigator will carefully observe each subject for any sign or symptom of adverse events.

Conditions

• Healthy
• Pharmacokinetics of ASP2408

Interventions

Type	Name	Description
DRUG	ASP2408	subcutaneous administration
DRUG	Placebo	subcutaneous administration

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2014-05-16
• Last updated: 2014-07-01

Locations

1 site across 1 country: Japan