The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a screening visit and if eligible and consenting, will attend to participate in the study within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing when each subject will receive a single intravenous dose of GSK3050002 or placebo, then remain in house under supervision until discharged on Day 3. Subjects will then return for 7 outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be 7-14 days following the last visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
GSK3050002 is a white to off-white lyophilized powder that will be reconstituted with sterile water for intravenous infusion. It is available in the concentrations of 0.1 milligram (mg)/kg, 0.5 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg.
Placebo contains normal saline (0.9% sodium chloride) for intravenous infusion
GSK Investigational Site
Cambridge, United Kingdom
Number of subjects with adverse events
Adverse events will be collected from the start of study treatment until the follow-up contact
Time frame: Up to Day 98
Laboratory measurements
Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
Time frame: Up to Day 98
Electrocardiogram (ECG) assessment as a measure of safety
Triplicate 12-lead ECG will be recorded before dosing on Day 1 (Pre-dose) and a single 12-lead ECG will be obtained at all other timepoints
Time frame: Up to Day 98
Vital signs as a measure of safety
Vital sign measurements will include systolic and diastolic blood pressure, temperature, and pulse rate
Time frame: Up to Day 98
Pharmacokinetic (PK) parameters after a single intravenous dose of GSK3050002
The following PK parameters will be determined: maximum observed serum concentration (Cmax), time to Cmax (tmax), area under the serum concentration-time curve (AUC\[0-t\] and AUC\[0-infinity\]), and apparent terminal phase half-life (t1/2)
Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84
Chemokine (C-C motif) ligand 20 (CCL20) levels in blood
Whole blood may be collected for in vitro stimulation and measurement of CCL20 activity in a biological assay. Analysis of serum levels of total (free and drug bound) CCL20 may be performed
Time frame: Up to Day 87
Immunogenicity development as assessed from anti-drug antibody
An assay for detecting anti-drug antibodies (ADA) against GSK305002 will be developed and validated using an electrochemiluminescent (ECL) bridging assay. Testing will be performed using the typical tiered approach involving screening, confirmation, and titration assays. If sera contain potential anti- GSK3050002 antibodies, they will be confirmed by immunocompetition using excess drug. Confirmed samples with such antibodies will be further analyzed for titers and may be characterized for neutralizing activity by a neutralization assay
Time frame: Up to Day 87
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.