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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154837
• Other study ID #: 221531
• Secondary ID: 2023-506880-32-0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: March 13, 2026

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: March 13, 2026
• Est. primary completion date: March 13, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 (>=) 50% 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/mcL at screening
• Former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening
• 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).

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK3862995B
GSK3862995B will be administered.
• Placebo
Placebo will be administered.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 40 weeks
Primary	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 40 weeks
Primary	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 40 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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 40 weeks
Secondary	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 40 weeks
Secondary	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
Secondary	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 40 weeks
Secondary	Part A: Change From Baseline in Absolute and Relative Blood Eosinophil Count	Change from baseline in absolute and relative blood eosinophil count will be assessed.	Baseline and up to 28 weeks
Secondary	Part B: Change From Baseline in Absolute and Relative Blood Eosinophil Count	Change from baseline in absolute and relative blood eosinophil count will be assessed.	Baseline and up to 40 weeks