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)

A Randomized, Double-blind, Placebo Controlled, Single and Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Inhaled GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
GSK3923868
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Timeline & enrollment
Phase
Phase 1
Start date
Jan 13, 2023
End date
Aug 18, 2023
Enrollment
12 participants
Primary outcome

Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs),Number of participants with AEs and SAEs,Number of participants with clinically significant changes in laboratory values, vital signs,12-lead Electrocardiogram (ECG) and spirometry measurements up to Follow Up,Number of participants with clinically significant changes in laboratory values, vital signs, ECG and spirometry measurements up to Follow Up

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.

ICD-10 classifications
Chronic obstructive pulmonary disease, unspecifiedOther chronic obstructive pulmonary diseaseOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05677347
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05677347 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Pulmonary Disease, Chronic Obstructive. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.