Phase I Clinical Trial

The first trial in human subjects after animal testing of the medication, the main aims of which are to ascertain the range of tolerable doses in humans, establish the toxicity profile, and understand the pharmacokinetics (absorption, distribution, metabolism and excretion) of the medication in humans. Research subjects are, therefore, healthy volunteers.

Objectives

This Phase I study was conducted to determine the safety profile of Coriolus Versicolor PSP in healthy humans. Treatment side effects, such as abdominal pain, diarrhea, constipation, anorexia, headache, rash, itchiness, fever, palpitation, chest tightness and abnormal urine tests, were noted.

Participants

16 healthy volunteers and 5 patients with breast cancer who were postsurgery.

Dose and administration

Coriolus Versicolor PSP administered after meals for 30 days. With reference to the recommended dose of 3.0 g/day for a healthy individual, participants in this study were divided into 3 groups:
– Group A: received Coriolus Versicolor PSP 2.0 g/day
– Group B: received Coriolus Versicolor PSP 4.0 g/day
– Group C: received Coriolus Versicolor PSP 6.0 g/day
No other medications were taken during this period.

Results

All doses evaluated in the study, including the reference dose of 3.0 g/
day and 6.0 g/day were not associated with significant side effects. This
study showed that participants had:

  • No abnormal reactions after taking Coriolus Versicolor PSP
  • Significant increases in appetite
  • No changes on electrocardiogram
  • No changes in liver and kidney function
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Conclusions

Daily doses of 3.0 g and 6.0 g of Coriolus Versicolor PSP were not associated with significant side effects in healthy participants.