First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 4, 2015

Primary Completion Date

June 2, 2016

Study Completion Date

June 2, 2016

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG

GSK3008348 Nebuliser solution

Nebuliser solution formulated at 5000 mcg/mL with 5% mannitol, citric acid, sodium citrate and water for injection, pH adjusted using Hydrochloric acid or Sodium hydroxide to the target pH 5.4 +/- 0.4. 4 ml of diluted dose of appropriate concentration will be administered by nebulisation.

DRUG

Placebo Nebuliser solution

5% mannitol nebuliser solution. 4 ml of solution will be administered by nebulisation

RADIATION

GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion

Formulated in 0.9% saline. The maximum amount of radioactivity injected during each PET scan will be 150 Megabecquerel (MBq) and maximum mass of \[18F\]-FBA-A20FMDV2 administered across all three administrations will be 100 mcg. Intravenous bolus infusion of 20 ml will be administered over about 30 seconds.

Trial Locations (1)

SE1 1YR

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY