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

May 27, 2026 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Ahrensburg, Germany, 22926
        • GSK Investigational Site
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 14050
        • GSK Investigational Site
      • Berlin, Germany, 10119
        • GSK Investigational Site
      • Dresden, Germany, 01069
        • GSK Investigational Site
      • Frankfurt, Germany, 60596
        • GSK Investigational Site
      • Hamburg, Germany, 20253
        • GSK Investigational Site
      • Hamburg, Germany, Hamburg
        • GSK Investigational Site
      • Hanover, Germany, 30159
        • GSK Investigational Site
      • Immenhausen, Germany, 34376
        • GSK Investigational Site
      • Leipzig, Germany, 04207
        • GSK Investigational Site
      • Lübeck, Germany, 23552
        • GSK Investigational Site
      • Mainz, Germany, 55128
        • GSK Investigational Site
      • Schwerin, Germany, 19055
        • GSK Investigational Site
  • United Kingdom
      • Barnsley, United Kingdom, S75 3DL
        • GSK Investigational Site
      • Blackpool, United Kingdom, FY2 0JH
        • GSK Investigational Site
      • Cambridge, United Kingdom, CB2 0GG
        • GSK Investigational Site
      • Cannock, United Kingdom, WS11 0BN
        • GSK Investigational Site
      • London, United Kingdom
        • GSK Investigational Site
      • London, United Kingdom, HA1 3UJ
        • GSK Investigational Site
      • Manchester, United Kingdom, M23 9QZ
        • GSK Investigational Site
      • West Yorkshire, United Kingdom, LS10 1DU
        • GSK Investigational Site
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85365
        • GSK Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • GSK Investigational Site
      • Orange City, Florida, United States, 32763
        • GSK Investigational Site
      • Plantation, Florida, United States, 33324
        • GSK Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78744
        • GSK Investigational Site

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy participants (Part A)

  • 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

Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Dose Level 1: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Experimental: Part A Dose Level 2: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Experimental: Part A Dose Level 3: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Experimental: Part A Dose Level 4: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Experimental: Part A Dose Level 5: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Experimental: Part A Dose Level 6: Single dose of GSK3862995B
Healthy participants will receive single dose of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Placebo Comparator: Part A: Placebo
Healthy participants will receive single dose of placebo.
Drug: Placebo
Placebo will be administered.
Experimental: Part B: Repeat dose of GSK3862995B
Participants with COPD will receive repeat doses of GSK3862995B.
Drug: GSK3862995B
GSK3862995B will be administered.
Placebo Comparator: Part B: Placebo
Participants with COPD will receive repeat doses of placebo.
Drug: Placebo
Placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 36 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Up to 36 weeks
Part B: Number of Participants with AEs and SAEs
Time Frame: Up to 48 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Up to 48 weeks
Part A: Number of Participants with Clinically significant changes in laboratory values
Time Frame: Up to 28 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in vital signs
Time Frame: Up to 28 weeks
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Time Frame: Up to 28 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Up to 28 weeks
Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis)
Time Frame: Up to 42 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in vital signs
Time Frame: Up to 42 weeks
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) up to end of intervention period will be assessed.
Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Time Frame: Up to 42 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Up to 42 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Maximum Concentration (Cmax)
Time Frame: Up to 28 weeks
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Up to 28 weeks
Part A: Area Under the Concentration-time Curve to the Last Quantifiable Concentration [AUC(0-t)]
Time Frame: Up to 28 weeks
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.
Up to 28 weeks
Part A: Area Under the Concentration-time Curve to the Infinity (inf) [AUC(0-inf)]
Time Frame: Up to 28 weeks
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Up to 28 weeks
Part B: Area Under the Concentration-time Curve Over the Dosing Interval [AUC(0-tau)]
Time Frame: Up to 42 weeks
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Up to 42 weeks
Part B: Cmax
Time Frame: Up to 42 weeks
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Up to 42 weeks
Part A: Number of Participants with Anti-Drug Antibodies (ADA) against GSK3682995B
Time Frame: Up to 28 weeks
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Up to 28 weeks
Part B: Number of participants with Incidence of Anti-Drug Antibodies (ADA) against GSK3682995B
Time Frame: Up to 42 weeks
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Up to 42 weeks
Part A: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Time Frame: Baseline and up to 28 weeks
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
Baseline and up to 28 weeks
Part B: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Time Frame: Baseline and up to 42 weeks
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
Baseline and up to 42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 221531
  • 2023-506880-32 (Other Identifier: EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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