Safety Tests: Human Clinical Studies
(1) An Oral Safety Study of NK-Containing Food, NSK II
* Randomized, Double-blinded Study
* 31 participants (22=Nattokinase group, 3 capsules/day, 9=placebo group)
* 4 weeks + 2-wk observation
* Result: Safe
(2) Clinical Study of Effect and Safety of NK Administration on CV Patients with Warfarin
* Double-blind, Placebo Controlled Study
* 60 participants with cardiovascular disease (taking warfarin)
* Low dose: 15=1,700FU/ day, 15=placebo
* High dose: 15=3,400FU/ day, 15=placebo
* 26 weeks
* Result: Safe
(3) An Open Clinical Pilot Study to Evaluate the Safety & Efficacy of NK as an Add-on Oral Fibrinolytic Agent to low Molecular Weight Heparin & Anti-platelet in acute ischemic stroke
* Prospective Multicenter proof of concept open pilot study
* 12 participants in hospital after a stroke (taking heparin & antiplatelet drugs)
* 6,000FU/ day for 7 days + 90-day monitoring
* Result: Safe
Safety Tests: Animal & Microorganism
Single Oral Toxicity Study
* Max. Dose: 1,000 mg/kg per day
* Result: No Influence
13-Weeks Oral Toxicity Study
* Max. Dose: 1,000 mg/kg per day
* Result: No Influence
Reverse-Mutation Assay (Ames Test)
Result: Negative
Chromosomal Aberration Test
Result: Negative
Pathogenicity Study of Nattokinase Producing Bacteria
Result: No Influence