The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.
This study will be the first investigation of GSK1995057 in humans and is primarily designed to investigate safety and tolerability of single and repeat intravenously infused doses. The study will enrol healthy male subjects and healthy female subjects of non-child bearing potential and will also investigate immunogenicity, GSK1995057 distribution (pharmacokinetics), and potential impact on indicators of host immunity and normal immunological function. Safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic data from this trial may facilitate further clinical investigations in healthy subjects dosed with GSK1995057 via the inhaled route, and ultimately clinical trials in patients with acute lung injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
56
Single intravenous dose
Single intravenous dose
GSK Investigational Site
Harrow, Middlesex, United Kingdom
Occurance of adverse events.
Number and type of adverse events recorded during study.
Time frame: From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).
Change from baseline in blood pressure.
Systolic and diastolic blood pressure values before and after dosing completion.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in heart rate.
Heart rate before and after dosing completion.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in respiration rate.
Respiration rate before and after dosing completion.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in body temperature.
Body temperature before and after dosing completion.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in heart function.
Holter recording.
Time frame: For 24hrs during screening, then for 1 hour before dosing to 24 hours after dosing starts (in Part A subjects only, except for cohort 7).
Change from baseline in heart function
Lead II cardiac telemetry.
Time frame: From 1 hour before dosing to 12 hours after dosing starts for each dose.
Change from baseline in heart function.
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12-lead ECG recording.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in lung function.
FEV1 and FVC measurements.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in laboratory safety data.
Clinical chemistry, haematology and routine urinalysis.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Plasma pharmacokinetics of GSK1995057
Levels of GSK1995057 in blood samples.
Time frame: From the first day of dosing until 48 hours after the completion of dosing.
Urine pharmacokinetics of GSK1995057
Levels of GSK1995057 in urine samples from cohort 6 subjects only.
Time frame: From 1 hour before the only dose until 48 hours after the dose.
Bronchoalveolar lavage fluid (BALF) (saline flushed into and then collected from a lung) pharmacokinetics.
Levels of GSK1995057 in BALF from cohort 7 subjects only.
Time frame: At 2 hrs after the completion of the only dose.
Effect of GSK1995057 on host immunity and immunological function
Levels of pharmacodynamic and immune function biomarkers in blood samples.
Time frame: From the day before dosing starts to 28 days after dosing completion.
Effects of GSK1995057 on host immunity and immunological function
Levels of pharmacodynamic and immune function biomarkers in BALF from cohort 7 subjects only.
Time frame: At 2 hrs after the completion of the only dose.
Immunogenic effect of GSK1995057
Levels of anti-GSK1995057 antibodies in blood samples
Time frame: From the start of screening (cohorts 1-4 only) or from the day before the start of dosing until 84 days after the completion of single or repeat dosing.