The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects. This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Quintiles
London, United Kingdom
Treatment Emergent Adverse Events
Time frame: up to 14 days post dose
Immunogenicity
Anti-drug antibody data
Time frame: Up to 28 days post dose
Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
Time frame: 5.5 hours post dose
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 12 time-points up to 48 hours post dose
Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 12 time-points up to 48 hours post dose
Pharmacokinetic Parameters: Terminal Half-life (t1/2)
Time frame: Up to 12 time-points up to 48 hours post dose
Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity
Time frame: Up to 12 time-points up to 48 hours post dose
Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
Time frame: 5.5 hours post dose
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