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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease - Trial NCT06154837

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.

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NCT06154837
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06154837
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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

Study Focus

GSK3862995B

Interventional

drug

Sponsor & Location

GlaxoSmithKline

Cambridge, United Kingdom

Timeline & Enrollment

Phase 1

Nov 27, 2023

Mar 13, 2026

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, unspecified
Other chronic obstructive pulmonary disease
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT06154837

Non-Device Trial