43 healthy male subjects, age 19-45 yrs. Nonsmokers
Conditions
Interventions
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 i
Sponsors
Medical University Vienna, Dept. of Clinical Pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs - Blood donation during the previous 3 weeks - History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: Markers of inflammation and oxidative stress, ? MAP, ? pulse rate, subjective symptoms and body temperature; antibodies against rhSOD.;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 | — |
Countries
Austria
Outcome results
None listed