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GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being developed for the treatment of rheumatoid arthritis. This study is being done in healthy volunteers to verify the safety and tolerability of GSK182771
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 with the starting dose of 0.3 milligram (mg) |
|
| Subjects receiving placebo in sub-cohort Xa (Cohort 1-5) | Placebo Comparator | Eligible subjects will receive placebo matching to GSK1827771 |
|
| Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 via injection |
|
| Subjects receiving placebo in sub-cohort Xb (Cohort 1-5) | Placebo Comparator | Eligible subjects will receive placebo matching to GSK1827771 |
|
| Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5) | Experimental | Eligible subjects will receive GSK1827771 via injection |
|
| Subjects receiving placebo in sub-cohort Xc (Cohort 1-5) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1827771 | Drug | GSK1827771 will be administered using injection via subcutaneous (SC) route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal clinical chemistry findings | Blood samples will be collected at specific time points as a measure of safety | Up to 29 days |
| Number of subjects with abnormal clinical hematology findings | Blood samples will be collected at specific time points as a measure of safety | Up to 29 days |
| Number of subjects with abnormal urinalysis findings | Urine samples will be collected at specific time points as a measure of safety | Up to 29 days |
| Number of subjects with abnormal blood pressure values | Systolic and diastolic blood pressure will be measured in a supine position after at least 5 minutes of rest as a measure of safety. | Up to 29 days |
| Number of subjects with abnormal heart rate values | Heart rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety. | Up to 29 days |
| Number of subjects with abnormal respiratory rate values | Respiratory rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety. | Up to 29 days |
| Number of subjects with abnormal body temperature findings | Body temperature will be measured in a supine position after at least 5 minutes of rest as a measure of safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of GSK1827771 | Blood samples will be collected at specific time points for calculating plasma concentrations of GSK1827771 | Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28 |
| Maximum plasma concentration (Cmax) of GSK1827771 |
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Inclusion Criteria:
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 | Evansville | Indiana | 47714 | United States | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo Comparator |
Eligible subjects will receive placebo matching to GSK1827771 |
|
| Placebo | Drug | Placebo to GSK1827771 for Injection will be administered via SC route |
|
| Up to 29 days |
| Number of subjects with abnormal electrocardiogram (ECG) findings | 12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety | Up to 29 days |
| Number of subjects with adverse events (AEs) | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to 29 days |
Blood samples will be collected at specific time points for calculating Cmax of GSK1827771 |
| Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28 |
| Area under the curve (AUC) of GSK1827771 | Blood samples will be collected at specific time points for calculating AUC of GSK1827771 | Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 1; in morning and evening on Day 2-7; in morning on Day 14, 21, 28 |
| Frequency of anti-GSK1827771 | The presence of anti-GSK1827771 binding antibodies will be assessed using an immunoelectrochemiluminescence screening assay (ECL). | Up to 29 days |
| Titer of anti-GSK1827771 | Blood samples for determination of anti-GSK1827771 antibodies will be taken at specific time points. | Up to 29 days |
| Frequency of anti-PEG | Antibodies to PEG components of GSK1827771 will be measured. | Up to 29 days |
| Titer of anti-PEG | Antibodies to PEG components of GSK1827771 will be measured. | Up to 29 days |
| Frequency of anti-dAb | Antibodies to dAb components of GSK1827771 will be measured. | Up to 29 days |
| Titer of anti-dAb | Antibodies to dAb components of GSK1827771 will be measured. | Up to 29 days |
| Change from Baseline response of whole blood to ex vivo stimulation with IL-1 alpha or IL-1 beta | Blood samples will be collected for assessment of pharmacodynamic activity of GSK1827771 at specific time points | Baseline and up to 29 days |
| Exploratory biomarker levels in blood | Blood samples will be taken for exploratory biomarker analysis | Up to 29 days |
| Baltimore |
| Maryland |
| 21225 |
| United States |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |