drugset / Trial / NCT04585009

Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics

NCT04585009 ↗

Phase 1 Completed 56 enrolled GlaxoSmithKline
RandomizedSequentialDouble-blindTreatment

Summary

This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.

Timeline

Start
2020-10-12
Primary completion
2022-06-16
Completion
2022-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK3923868 Unknown 50 ug Inhaled
Subject GSK3923868 Unknown 100 ug Inhaled
Subject GSK3923868 Unknown 250 ug Inhaled
Subject GSK3923868 Unknown 500 ug Inhaled
Subject GSK3923868 Unknown 1000 ug Inhaled
Subject GSK3923868 Unknown 3000 ug Inhaled