Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-25 @ 3:01 AM
Study NCT ID:
NCT02134834
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Sponsor:
Meiji Seika Pharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
Status:
COMPLETED
Status Verified Date:
2014-12
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 objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.
Detailed Description:
None
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?: