Report On Phase Ⅰ And Phase Ⅱ Clinical Trials Of κ-Selenocarrageenan

To evaluate the clinical usefulness of κ-Selenocarrageenan in immunomodulation, we completed phase I and phase II clinical trials. The aim of the phase I clinical trial was to examine the drug tolerance and pharmacokinetics, the study was conducted in 12 patients with malignances and 15 healthy volunteers, respectively. They were divided to receive oral κ-selenocarrageenan in designed doses and conditions. From this study, it was revealed that κ -selenocarrageenan had no apparent toxicity to vital organs such as heart, liver, lung and kidney except for dizziness and slightly nausea in very few patients when they took 100mg of the drug per day. Immune functions were enhanced and levels of β₂-microglobulins (β₂-MG) in blood and urine were decreased when the patients took 30mg to 50mg per day. Recommended doses for phase II clinical trial were: (1) the doses of κ-selenocarrageenan were 30mg to 50mg per day for the purpose of immunomodunation in convalescents; (2) the doses of κ-selenocarrageenan were 50mg per day during the chemotherapy or radiotherapy or 100mg per day for two weeks during the periods of three weeks in order to decrease side effects of the chemotherapy of radiotherapy.The concentrations of serum selenium were determined by...