NCT04585009

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	GSK3923868	GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
DRUG	Matching placebo	Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.
DEVICE	Monodose RS01	Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Timeline

• Start date: 2020-10-12
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2020-10-14
• Last updated: 2024-02-20
• Results posted: 2024-02-20

Locations

1 site across 1 country: United Kingdom