Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 1:22 AM
Study NCT ID:
NCT02125435
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
Detailed Description:
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: