This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy subjects. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The study also investigated the effects of age on the PK of PA-001 prior to patient studies.
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Incidence and severity of adverse events after single and multiple IV dosed of PA-001 in healthy subjects
Timeframe: For approx. 8 weeks
Incidence of laboratory abnormalities (hematology, clinical chemistry and urinalysis test)
Timeframe: For approx. 8 weeks
12-lead electrocardiogram parameters
Timeframe: For approx. 8 weeks