Dataset from A Randomised Double-blind (Sponsor Open), Placebo Controlled, Single Ascending Dose, First Time in Human Study in Participants With Mild to Moderate Asthma to Assess Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3511294 Administered Subcutaneously

GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known
to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating
population of eosinophils. This is a single ascending dose FTIH study to investigate safety,
tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3511294,
administered SC in subjects with mild to moderate asthma maintained on a low-medium daily
dose of inhaled corticosteroids (ICS) or ICS/long acting beta-agonist (LABA), and short
acting beta-agonist (SABA). The subjects will attend a pre-screen visit of up to 12 weeks
before dosing for assessment of blood eosinophils. Eligible subjects with blood eosinophils
>=200 cells per microliter (cells/µL) will undergo a screening period of up to 4 weeks. The
subjects will then be randomized into 5 cohorts. In each cohort, the subjects will be
randomized to receive a single dose of GSK3511294 or placebo in a ratio of 3:1. The follow-up
period will be up to 40 weeks post dose and will be dose-dependent. The scheduled maximum
duration for each subject will be up to 44 weeks including up to 28 days of screening.