drugset / Trial / NCT05677347

Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05677347 ↗

Phase 1 Completed 12 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.

Timeline

Start
2023-01-23
Primary completion
2023-07-20
Completion
2023-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK3923868 Unknown 500 ug Inhaled
Subject GSK3923868 Unknown 1000 ug Inhaled
Subject GSK3923868 Unknown 1500 ug Inhaled