First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 17, 2017

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Asthma
Interventions
DRUG

GSK3511294

GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.

DRUG

Placebo

Matching Placebo will consist of 0.9% w/v sodium chloride which will be administered by the SC route.

DRUG

Salbutamol/albuterol

Salbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.

Trial Locations (5)

14050

GSK Investigational Site, Berlin

30625

GSK Investigational Site, Hanover

HA1 3UJ

GSK Investigational Site, Harrow

NW10 7EW

GSK Investigational Site, London

M23 9QZ

GSK Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03287310 - First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma | Biotech Hunter | Biotech Hunter