A Phase 1 Ethnobridging trial to assess Safety, Tolerability and PK of single doses of GSK3923868
Research type
Research Study
Full title
A phase 1, randomized, double-blind, placebo controlled, parallel group study of the safety, tolerability and pharmacokinetics of single doses of GSK3923868 administered via dry powder inhaler to healthy participants of Chinese, Japanese and European ancestry.
IRAS ID
1010098
Contact name
Alex West
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
The trial will be performed at a single site and neither the site staff or the study participants will know if they are receiving an active or placebo dose. The study will be conducted in the UK, and GSK will be the study sponsor. This study will include healthy males and females between the ages of 18 to 50. There will be a total of 30 participants recruited in this study. Of those, 10 will be of Japanese ancestry, 10 will be of Chinese ancestry and 10 will be of European ancestry.
The study drug to be tested in this trial is GSK3923868, this study drug is under development by GSK for the treatment of rhinovirus (common cold virus) infections in patients with chronic obstructive pulmonary disease (COPD). In healthy individuals an infection with rhinovirus generally leads to mild symptoms limited to the upper respiratory tract, such as a blocked or runny nose and a sore throat, from which people usually recover in less than 2 weeks. However, in patients with pre-existing conditions such as COPD, an infection with rhinoviruses can lead to a worsening of symptoms (known as an "exacerbation"), such as coughing, wheezing and shortness of breath. Occasionally these can be life-threatening. In patients with COPD, an infection with rhinoviruses is one of the main causes of the deterioration of their disease
GSK3923868 will be administered in this clinical study as a dry powder for inhalation using an inhaler device called the ELLIPTA inhaler. Drugs that work in this way are currently not approved and available.
This study is being performed to test if the study drug is safe and well-tolerated after inhalation of single dose in healthy people of Japanese, Chinese and European ancestry to support future studies that may be performed in Japan or China.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0376
Date of REC Opinion
24 Jul 2024
REC opinion
Further Information Favourable Opinion