Impact of rhCu/Zn SOD on inflammation-induced impairment of vascular reactivity

INTERVENTION: Trade Name: recombinant human Cu/Zn superoxide dismutase (rhSOD) sudismase Product Name: recombinant human Cu/Zn superoxide dismutase (rhSOD) Product Code: sudismase Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intraarterial use CONDITION: 43 healthy male subjects, age 19‐45 yrs. Nonsmokers PRIMARY OUTCOME: Main Objective: 1. To investigate the pharmacokinetic profile of a recombinant human superoxide dismutase (rhSOD) in healthy volunteers.; 2. To investigate the effect of a recombinant human superoxide dismutase (rhSOD) on impaired vascular reactivity during acute inflammation in healthy volunteers; Primary end point(s): ‐ Plasma concentrations of rhSOD; ; ‐ forearm blood flow: Change over baseline in response to vasoactive drugs ; will be expressed as delta of percentages; Secondary Objective: Markers of inflammation and oxidative stress, ? MAP, ? pulse rate, subjective symptoms and body temperature; antibodies against rhSOD. INCLUSION CRITERIA: ‐ Men aged between 18 and 45 years ‐ Nonsmoker ‐ Body mass index between 15th and 85th percentile (Must et al. 1991) ‐ Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range