An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics.

Summary

GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. There will be two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

DRUG

2 ng GSK2445053

2ng GSK2445053 administered intranasally

DRUG

20ng GSK2445053

20ng GSK2445053 administered intranasally

DRUG

100ng GSK2445053

100ng GSK2445053 administered intranasally

DRUG

200ng GSK2445053

200ng GSK2445053 administered intranasally

DRUG

400ng GSK2445053

400ng GSK2445053 administered intranasally

DRUG

1000ng GSK2445053

1000ng GSK2445053 administered intranasally

DRUG

2000ng GSK2445053

2000ng GSK2445053 administered intranasally

DRUG

4000ng GSK2445053

4000ng GSK2445053 administered intranasally

DRUG

Placebo

Placebo administered intranasally

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-30

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• Netherlands

Study Locations