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NCT06154837

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Pulmonary Disease, Chronic Obstructive
Drug/Device/Intervention
GSK3862995B
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Cambridge, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Nov 27, 2023
End date
Mar 13, 2026
Enrollment
130 participants
Primary outcome

Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs),Part B: Number of Participants with AEs and SAEs,Part A: Number of Participants with Clinically significant changes in laboratory values,Part A: Number of Participants with Clinically Significant Change in vital signs,Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters,Part B: Number of Participants with Clinically significant changes in laboratory values. (haematology, chemistry and urinalysis),Part B: Number of Participants with Clinically Significant Change in vital signs,Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters

Summary

The primary objective of the study is to investigate the safety and tolerability of ascending
 doses of GSK3862995B following single dose in healthy participants and repeat doses in
 participants with Chronic obstructive pulmonary disease (COPD).

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
NCT06154837
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06154837 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 130 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.