Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT00907933
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal SB-705498 in Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to Examine the Safety, Tolerability and Pharmacokinetics of a) Single, Ascending and b) Twice-daily Repeat Doses of Intranasal SB-705498
Status:
COMPLETED
Status Verified Date:
2017-07
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:
This is a First Time in Human (FTIH) study to investigate the safety, tolerability and pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single intranasal 498 dosing will be assessed and established before initiating the evaluation of repeat intranasal 498 dosing.
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?: