Related Experiment Video
Updated: May 22, 2026

Measuring Trans-Plasma Membrane Electron Transport by C2C12 Myotubes
Published on: May 4, 2018
Human pharmacokinetics of intravenous recombinant human Cu/Zn superoxide dismutase
Georg Schaller1, Peter Dittrich, Manuela Felizeter
1Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Objective:
Oxidative stress plays an important role in human disease, but antioxidant therapies are limited. Under physiological conditions superoxide is controlled by the enzyme superoxide dismutase. A recombinant human Cu/Zn superoxide dismutase (rhSOD) might open new therapeutic possibilities.
Methods:
Safety profile and pharmacokinetics in plasma and urine were assessed in an open label phase I study with dose-escalation. 18 healthy male volunteers received a single intravenous 10-minute infusion of 150, 300, or 600 mg rhSOD, respectively (n = 6 per dose group).
Results:
rhSOD was well tolerated. Peak plasma concentrations (cmax; mean ± SD) were reached at the end of infusion, with 32.96 ± 10.31, 51.60 ± 8.23, and 103.90 ± 19.02 μg/ ml, respectively. Non-compartmental halflife was 1.06 ± 0.37, 1.59 ± 0.64, and 1.63 ± 0.28 hours. Urinary excretion (10 h) showed dose-dependent relative increases with 11.28 ± 6.46 (7.5%), 54.93 ± 15.25 (18.3%), and 191.81 ± 104.60 mg (32.0%).
Conclusions:
Our results show a good safety profile and predictable pharmacokinetics of rhSOD, suggesting that therapeutic exploratory studies might be safely conducted in humans.
Related Concept Videos
Pharmacokinetic–Pharmacodynamic Relationship: Duration of Dose-Effect Relationship
Drug toxicity: Idiosyncratic Reactions
Pharmacogenetics of Phase I Enzymes: Cytochrome P450 Isozymes
Drug Accumulation During Multiple Dosing: Repetitive IV Injections

