RECRUITING

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

Conditions

Pulmonary Disease, Chronic Obstructive GSK3862995B Chronic Obstructive Pulmonary Disease Phase 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-11-27

Study Completion:2026-06-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06154837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant must be 18 to 65 years of age inclusive. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Body weight within the range 50-110 kilogram (kg) (inclusive) * Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m\^2) * Male and/or female of non-childbearing potential * Participant must be 40 to 75 years of age inclusive. * Body weight within the range 50-110 kg (inclusive) * BMI within the range 19.5-32 kg/m\^2 * Participant has a confirmed diagnosis of COPD for greater than (\>)12 months * Participants must present with a measured post-salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (\<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (\>=) 40% of predicted normal values. * Participants must have a well-documented requirement for optimized standard of care background therapy that includes daily inhaled medication. * A peripheral blood eosinophil count of \>=150 cells/microliter (mcL) at screening * Former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted * Male and/or female of non-childbearing potential.	* Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints. * A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles). * Significant allergies to humanized monoclonal antibodies. * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years * Alanine transaminase (ALT) \>1x upper limit of normal (ULN) * Total bilirubin \>1.5xULN (isolated total bilirubin \>1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (\<) 35%). * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A clinically significant abnormality in 12-lead ECG readings performed at screening * A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).

Inclusion Criteria

Exclusion Criteria

* Participant must be 18 to 65 years of age inclusive.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Body weight within the range 50-110 kilogram (kg) (inclusive)
* Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m\^2)
* Male and/or female of non-childbearing potential
* Participant must be 40 to 75 years of age inclusive.
* Body weight within the range 50-110 kg (inclusive)
* BMI within the range 19.5-32 kg/m\^2
* Participant has a confirmed diagnosis of COPD for greater than (\>)12 months
* Participants must present with a measured post-salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (\<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (\>=) 40% of predicted normal values.
* Participants must have a well-documented requirement for optimized standard of care background therapy that includes daily inhaled medication.
* A peripheral blood eosinophil count of \>=150 cells/microliter (mcL) at screening
* Former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted
* Male and/or female of non-childbearing potential.

* Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
* A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles).
* Significant allergies to humanized monoclonal antibodies.
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years
* Alanine transaminase (ALT) \>1x upper limit of normal (ULN)
* Total bilirubin \>1.5xULN (isolated total bilirubin \>1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (\<) 35%).
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A clinically significant abnormality in 12-lead ECG readings performed at screening
* A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials

STUDY_DIRECTOR

GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site

Rock Hill, South Carolina, 29732

United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2026-06-26

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2026-06-26

Terms related to this study

Keywords Provided by Researchers

GSK3862995B
Chronic Obstructive Pulmonary Disease
Phase 1

Additional Relevant MeSH Terms

Pulmonary Disease, Chronic Obstructive