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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
GSK1827771 will be administered using injection via subcutaneous (SC) route.
Placebo to GSK1827771 for Injection will be administered via SC route
GSK Investigational Site
Evansville, Indiana, United States
GSK Investigational Site
Baltimore, Maryland, United States
Number of subjects with abnormal clinical chemistry findings
Blood samples will be collected at specific time points as a measure of safety
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 29 days
Number of subjects with abnormal electrocardiogram (ECG) findings
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety
Time frame: 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.
Time frame: Up to 29 days
Plasma concentrations of GSK1827771
Blood samples will be collected at specific time points for calculating plasma concentrations of GSK1827771
Time frame: 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
Blood samples will be collected at specific time points for calculating Cmax of GSK1827771
Time frame: 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
Time frame: 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).
Time frame: Up to 29 days
Titer of anti-GSK1827771
Blood samples for determination of anti-GSK1827771 antibodies will be taken at specific time points.
Time frame: Up to 29 days
Frequency of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Time frame: Up to 29 days
Titer of anti-PEG
Antibodies to PEG components of GSK1827771 will be measured.
Time frame: Up to 29 days
Frequency of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
Time frame: Up to 29 days
Titer of anti-dAb
Antibodies to dAb components of GSK1827771 will be measured.
Time frame: 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
Time frame: Baseline and up to 29 days
Exploratory biomarker levels in blood
Blood samples will be taken for exploratory biomarker analysis
Time frame: Up to 29 days