CLINICAL-STUDIES OF UKRAIN IN HEALTHY-VOLUNTEERS (PHASE-1)

Phase I of a clinical study of Ukrain was performed in 19 healthy outp atient volunteers. Their general clinical conditions were evaluated, a s well as the following parameters: biochemical, haematological, immun ological, electrolyte and trace elements, neopterin, immune complexes and non specific blocking factors. Ukrain was administered intramuscul arly (i. m.) or intra venously (i. v.) every one, two or three days in doses of 5 to 50 mg for 7 to 40 days. In one case the drug was admini stered for three years in the dose of 5 to 50 mg/injection in repeated courses. During the investigation no significant changes were found i n clinical states, During the intramuscuclar injections the volunteers felt only localized pain; some reported drowsiness, increased thirst and polyurea. There was a slight, insignificant increase in body tempe rature and negligible decrease of blood pressure in some cases. In con clusion, it can be said that Ukrain is well tolerated in healthy volun teers in the doses of 5, 10, 20, and 50 mg/injection, even during prol onged (up to three years) administration.