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

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: Active, not recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Placebo; Drug: GSK3862995B

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	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	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	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	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)	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	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	Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.	Up to 42 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Maximum Concentration (Cmax)	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)]	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)]	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)]	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	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	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	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	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	Ratio to baseline in absolute and relative blood eosinophil count will be assessed.	Baseline and up to 42 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 17, 2026

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: November 26, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; Chronic Obstructive Pulmonary Disease; GSK3862995B
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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