drugset / Trial / NCT00907933

Intranasal SB-705498 in Healthy Volunteers

NCT00907933

Phase 1 Completed 44 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2008-11-10
Primary completion
2009-02-11
Completion
2009-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject SB-705498 Small molecule 0.5 mg Intranasal
Subject SB-705498 Small molecule 1.5 mg Intranasal
Subject SB-705498 Small molecule 3 mg Intranasal
Subject SB-705498 Small molecule 6 mg Intranasal
Subject SB-705498 Small molecule 12 mg Intranasal

Indications