GSK3862995B
DrugGSK3862995B will be administered.
NCT Number: NCT06154837
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Ahrensburg, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy participants (Part A)
Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)
Exclusion criteria
GSK3862995B will be administered.
Placebo will be administered.
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.
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.
Time frame: Up to 28 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
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.
Time frame: Up to 28 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Time frame: Up to 42 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
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.
Time frame: Up to 42 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
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.
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.
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.
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.
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.
Time frame: Up to 28 weeks
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Time frame: Up to 42 weeks
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Time frame: Baseline and up to 28 weeks
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
Time frame: Baseline and up to 42 weeks
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
GlaxoSmithKline
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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