This is a Phase 1b, single center study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3923868 following repeat doses in mild asthmatics during experimental human rhinovirus 16 (HRV-16) infection. The study will be conducted in two parts. Part A will determine the efficacy of GSK3923868 administration after viral inoculation (i.e., therapeutic treatment) and Part B may be undertaken to determine the efficacy of GSK3923868 administration before viral inoculation (i.e., prophylactic treatment). The purpose of this study is to establish proof-of-mechanism that GSK3923868 treatment can reduce symptoms of Human Rhinovirus (HRV) infection in a controlled setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
GSK3923868 dose and administration as per study intervention.
Placebo matching GSK3923868 will be administered.
GSK Investigational Site
London, United Kingdom
Area under curve (AUC) of change from baseline (CfB) in total lower respiratory tract symptoms (LRTS) score from day of inoculation up to discharge
The LRTS includes cough, chest tightness, shortness of breath, wheezing, daily activity, and night time awakenings. Each symptom is assessed on a 4-point scale. The score ranges from 0 to 3, where higher points indicate more symptoms experienced and severity that restricts normal activities. Shortness of breath and wheezing will be measured on a 5-point scale and ranges from 0 to 4 in which 0 indicates no symptoms and 4 indicates symptoms at total rest and the highest level of disease severity. LRTS assessment is performed three times a day.
Time frame: Baseline and up to Day 15
Maximal CfB in total LRTS score from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
AUC and maximal CfB in total upper respiratory tract symptoms (URTS) score from day of inoculation up to discharge
The URTS includes nasal discharge, nasal obstruction, sneezing and sore throat. Each symptom will be assessed on a 4-point scale, where 0 indicates no symptom and a higher point for more symptoms and severity that restricts normal activities.
Time frame: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in trough force expiratory volume (FEV1) from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in morning and evening peak expiratory flow (PEF) from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 22
Number of participants with clinically significant changes in vital signs
Time frame: Up to Day 22
Number of participants with clinically significant changes in electrocardiogram (ECG)
Time frame: Up to Day 22
Number of participants with clinically significant changes in clinical laboratory parameters
Time frame: Up to Day 22
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.