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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK3923868 | Unknown | 500 ug | Inhaled |
| Subject | GSK3923868 | Unknown | 1000 ug | Inhaled |
| Subject | GSK3923868 | Unknown | 1500 ug | Inhaled |