Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD) - Trial NCT05677347
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.
Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1
Jan 13, 2023
Aug 18, 2023
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
Data Source
ClinicalTrials.gov
NCT05677347
Non-Device Trial