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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
GSK3862995B will be administered.
Placebo will be administered.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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GSK Investigational Site
Yuma, Arizona, United States
RECRUITINGGSK Investigational Site
Hialeah, Florida, United States
RECRUITINGGSK Investigational Site
Plantation, Florida, United States
RECRUITINGGSK Investigational Site
Columbus, Georgia, United States
RECRUITINGGSK Investigational Site
Shelby, North Carolina, United States
RECRUITINGGSK Investigational Site
Wilmington, North Carolina, United States
RECRUITINGGSK Investigational Site
Medford, Oregon, United States
RECRUITINGGSK Investigational Site
Rock Hill, South Carolina, United States
RECRUITINGGSK Investigational Site
Austin, Texas, United States
RECRUITINGGSK Investigational Site
Ahrensburg, Germany
RECRUITING...and 22 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 42 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.
Time frame: 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.
Time frame: Up to 28 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and up to 42 weeks