Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 6:43 PM
Study NCT ID:
NCT01570205
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers
Sponsor:
Xigen SA
Organization:
Study Overview
Official Title:
The Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Male Volunteers in a Randomized, Double Blind, Placebo Controlled, Dose Escalating Phase I Study
Status:
COMPLETED
Status Verified Date:
2012-04
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 the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers
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?: