Safety, tolerability and pharmacokinetics of inhaled GSK3923868
Research type
Research Study
Full title
A randomised double-blind, placebo controlled, single ascending and repeat dose, First Time in Human study in healthy participants and stable asthmatics to assess safety, tolerability and pharmacokinetics of GSK3923868 inhalation powder.
IRAS ID
284326
Contact name
Catherine Muya
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2020-002203-19
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Research Summary
GlaxoSmithKline (GSK) is developing a drug (GSK3923868) to treat human rhinovirus (HRV), which belongs to a family of viruses called picornaviruses. Rhinoviruses cause nose, throat and chest infections. They are the most common cause of the cold. Symptoms of the common cold include a blocked nose, sore throat, headache and muscle aches. Patients usually recover in under 2 weeks. However, in patients with conditions like chronic obstructive pulmonary disease (COPD) and asthma, infection can cause worsening of symptoms (exacerbations) through infection of the lungs. Exacerbations cause serious illness that can trigger hospitalisation or death.
There are no treatments or vaccines for HRV, except medicines that reduce symptoms. GSK3923868 disrupts the process the virus uses to reproduce in the lung, which might improve patients’ ability to fight infections and reduce lung damage. If GSK3923868 works, it could provide a treatment option for patients with COPD and asthma to prevent exacerbations.
This is the first time GSK3923868 is studied in humans. The main objective is testing safety, tolerability and blood concentrations of single and repeat doses of inhaled GSK3923868 in healthy participants and patients with asthma. The results will inform the doses of GSK3923868 in future studies.
Approximately 56 male and female (woman of non-childbearing potential) participants will be enrolled in the study, which consists of three parts: Parts A and B with approximately 40 healthy participants, and Part C with approximately 16 participants with asthma. Participants will be allocated randomly to receive a dose of either GSK3923868 or placebo.
While staying in the study centre, participants undergo close observation and multiple assessments will be carried out.
Participation has no direct benefit to participants. The study is sponsored by GSK and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited clinical research unit in the United Kingdom.
Summary of Results
https://www.gsk-studyregister.com/en/trial-details/?id=213497
REC name
HSC REC A
REC reference
20/NI/0104
Date of REC Opinion
11 Sep 2020
REC opinion
Further Information Favourable Opinion