GSK Investigational Site
London, E1 2AX, United Kingdom
NCT Number: NCT05398198
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
London, E1 2AX, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
If the methacholine challenge test is negative or the participant is unable to perform this test, bronchodilator reversibility is allowed as an alternative, assessed as follows:
Exclusion criteria
All participants:
GSK3923868 dose and administration as per study intervention.
Placebo matching GSK3923868 will be administered.
Time frame: Baseline and up to Day 15
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
Time frame: Baseline and up to Day 15
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
Time frame: Baseline and up to Day 15
Time frame: Up to Day 22
Time frame: Up to Day 22
Time frame: Up to Day 22
Time frame: Up to Day 22
GlaxoSmithKline
Industry
A Randomized, Double-blind, Placebo Controlled, Repeat Dose Phase 1b Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GSK3923868 During Experimental Human Rhinovirus Infection in Participants With Mild Asthma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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