NCT06154837

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Nov 2023

Typical duration for phase_1

Geographic Reach
3 countries

32 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2023Mar 2027

First Submitted

Initial submission to the registry

November 26, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

November 26, 2023

Last Update Submit

July 16, 2025

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GSK3862995BChronic Obstructive Pulmonary DiseasePhase 1

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (9)

  • Part A: Area Under the Concentration-time Curve to the Last Quantifiable Concentration [AUC(0-t)]

    Up to 28 weeks

  • Part A: Area Under the Concentration-time Curve to the Infinity (inf) [AUC(0-inf)]

    Up to 28 weeks

  • Part A: Maximum Concentration (Cmax)

    Up to 28 weeks

  • Part B: Area Under the Concentration-time Curve Over the Dosing Interval [AUC(0-tau)]

    Up to 42 weeks

  • Part B: Cmax

    Up to 42 weeks

  • +4 more secondary outcomes

Study Arms (9)

Part A Dose Level 1: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A Dose Level 2: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A Dose Level 3: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A Dose Level 4: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A Dose Level 5: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A Dose Level 6: Single dose of GSK3862995B

EXPERIMENTAL

Healthy participants will receive single dose of GSK3862995B.

Drug: GSK3862995B

Part A: Placebo

PLACEBO COMPARATOR

Healthy participants will receive single dose of placebo.

Drug: Placebo

Part B: Repeat dose of GSK3862995B

EXPERIMENTAL

Participants with COPD will receive repeat doses of GSK3862995B.

Drug: GSK3862995B

Part B: Placebo

PLACEBO COMPARATOR

Participants with COPD will receive repeat doses of placebo.

Drug: Placebo

Interventions

GSK3862995BDRUG

GSK3862995B will be administered.

Part A Dose Level 1: Single dose of GSK3862995BPart A Dose Level 2: Single dose of GSK3862995BPart A Dose Level 3: Single dose of GSK3862995BPart A Dose Level 4: Single dose of GSK3862995BPart A Dose Level 5: Single dose of GSK3862995BPart A Dose Level 6: Single dose of GSK3862995BPart B: Repeat dose of GSK3862995B
PlaceboDRUG

Placebo will be administered.

Part A: PlaceboPart B: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

GSK Investigational Site

Yuma, Arizona, 85365, United States

RECRUITING

GSK Investigational Site

Hialeah, Florida, 33016, United States

RECRUITING

GSK Investigational Site

Plantation, Florida, 33324, United States

RECRUITING

GSK Investigational Site

Columbus, Georgia, 31904, United States

RECRUITING

GSK Investigational Site

Shelby, North Carolina, 28150, United States

RECRUITING

GSK Investigational Site

Wilmington, North Carolina, 28412, United States

RECRUITING

GSK Investigational Site

Medford, Oregon, 97504, United States

RECRUITING

GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

RECRUITING

GSK Investigational Site

Austin, Texas, 78744, United States

RECRUITING

GSK Investigational Site

Ahrensburg, 22926, Germany

RECRUITING

GSK Investigational Site

Berlin, 10117, Germany

RECRUITING

GSK Investigational Site

Berlin, 10119, Germany

RECRUITING

GSK Investigational Site

Berlin, 14050, Germany

RECRUITING

GSK Investigational Site

Dresden, 01069, Germany

RECRUITING

GSK Investigational Site

Frankfurt, 60596, Germany

RECRUITING

GSK Investigational Site

Hamburg, 20253, Germany

RECRUITING

GSK Investigational Site

Hamburg, Hamburg, Germany

RECRUITING

GSK Investigational Site

Hanover, 30159, Germany

RECRUITING

GSK Investigational Site

Immenhausen, 34376, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04207, Germany

RECRUITING

GSK Investigational Site

Lübeck, 23552, Germany

RECRUITING

GSK Investigational Site

Mainz, 55128, Germany

RECRUITING

GSK Investigational Site

München, 81241, Germany

RECRUITING

GSK Investigational Site

Schwerin, 19055, Germany

RECRUITING

GSK Investigational Site

Barnsley, S75 3DL, United Kingdom

RECRUITING

GSK Investigational Site

Blackpool, FY2 0JH, United Kingdom

RECRUITING

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

RECRUITING

GSK Investigational Site

Cannock, WS11 0BN, United Kingdom

RECRUITING

GSK Investigational Site

London, HA1 3UJ, United Kingdom

RECRUITING

GSK Investigational Site

London, United Kingdom

RECRUITING

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

RECRUITING

GSK Investigational Site

West Yorkshire, LS10 1DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The primary purpose of the study is to evaluate the safety, and tolerability of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disorder (COPD).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 4, 2023

Study Start

November 27, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.
More information

Locations

GB(8)US(9)DE(15)