The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
ApTOLL will be administered as follows: * Day 1: a dose of 0.1mg/kg will be administered intravenously as a slow infusion. * Day 2: a dose of 0.1mg/kg will be administered intravenously as single bolus injection. * Day 3: a dose of 0.2mg/kg will be administered intravenously as single bolus injection.
Clinical Pharmacology Department. Hospital Universitario de La Princesa
Madrid, Spain
Adverse Events
To evaluate the safety and tolerability between different ways of ApTOLL administration: intravenous infusion versus bolus intravenous injection, and pharmacokinetic characteristics of ApTOLL in healthy volunteers after single dose administration in fasting conditions.
Time frame: day 1 to day 28
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