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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506880-32 | Other Identifier | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose Level 1: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. |
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| Part A Dose Level 2: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. |
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| Part A Dose Level 3: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. |
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| Part A Dose Level 4: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. |
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| Part A Dose Level 5: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. |
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| Part A Dose Level 6: Single dose of GSK3862995B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3862995B | Drug | GSK3862995B will be administered. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] |
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Inclusion Criteria:
Healthy participants (Part A)
Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Yuma | Arizona | 85365 | United States | ||
| GSK Investigational Site |
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/
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.
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.
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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).
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Healthy participants will receive single dose of GSK3862995B. |
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| Part A: Placebo | Placebo Comparator | Healthy participants will receive single dose of placebo. |
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| Part B: Repeat dose of GSK3862995B | Experimental | Participants with COPD will receive repeat doses of GSK3862995B. |
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| Part B: Placebo | Placebo Comparator | Participants with COPD will receive repeat doses of placebo. |
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| Placebo | Drug | Placebo will be administered. |
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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 |
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: 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 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 |
| Hialeah |
| Florida |
| 33016 |
| United States |
| GSK Investigational Site | Orange City | Florida | 32763 | United States |
| GSK Investigational Site | Plantation | Florida | 33324 | United States |
| GSK Investigational Site | Columbus | Georgia | 31904 | United States |
| GSK Investigational Site | Shelby | North Carolina | 28150 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | United States |
| GSK Investigational Site | Austin | Texas | 78744 | United States |
| GSK Investigational Site | Ahrensburg | 22926 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10119 | Germany |
| GSK Investigational Site | Berlin | 14050 | Germany |
| GSK Investigational Site | Dresden | 01069 | Germany |
| GSK Investigational Site | Frankfurt | 60596 | Germany |
| GSK Investigational Site | Hamburg | 20253 | Germany |
| GSK Investigational Site | Hamburg | Hamburg | Germany |
| GSK Investigational Site | Hanover | 30159 | Germany |
| GSK Investigational Site | Immenhausen | 34376 | Germany |
| GSK Investigational Site | Leipzig | 04207 | Germany |
| GSK Investigational Site | Lübeck | 23552 | Germany |
| GSK Investigational Site | Mainz | 55128 | Germany |
| GSK Investigational Site | Schwerin | 19055 | Germany |
| GSK Investigational Site | Barnsley | S75 3DL | United Kingdom |
| GSK Investigational Site | Blackpool | FY2 0JH | United Kingdom |
| GSK Investigational Site | Cambridge | CB2 0GG | United Kingdom |
| GSK Investigational Site | Cannock | WS11 0BN | United Kingdom |
| GSK Investigational Site | London | HA1 3UJ | United Kingdom |
| GSK Investigational Site | London | United Kingdom |
| GSK Investigational Site | Manchester | M23 9QZ | United Kingdom |
| GSK Investigational Site | West Yorkshire | LS10 1DU | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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