MedTrace Logo

Intranasal SB-705498 in Healthy Volunteers

NCT00907933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-07-13

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00907933 on ClinicalTrials.gov