NCT00907933

Intranasal SB-705498 in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rhinitis

Interventions

Type	Name	Description
DRUG	SB-705498	0.5mg intranasal SB-705498
DRUG	SB-705498	1.5mg intranasal SB-705498
DRUG	SB-705498	3mg intranasal SB-705498
DRUG	SB-705498	6mg intranasal SB-705498
DRUG	SB-705498	12mg intranasal SB-705498
DRUG	Placebo	Placebo '498
DRUG	SB-705498	6mg intranasal SB-705498 for 14 days bid
DRUG	SB-705498	12mg intranasal SB-705498 14 days bid
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-11-10
• Primary completion: 2009-02-11
• Completion: 2009-02-11
• First posted: 2009-05-25
• Last updated: 2017-07-13

Locations

1 site across 1 country: United Kingdom