Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
brief summary
Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.
detailed description
32 subjects (F: M=1:1) were randomized in three dose groups (0.25-0.5-1.0ug/kg/min). 8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; 12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects). All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic. At least 1 week should be kept between two dose groups. Escalation to the higher dose will occur after the lower dose group has been completed and no significant safety issues are found.
official title
A Phase I Dose Escalating Study Evaluating the Pharmacokinetics, Tolerability and Safety of Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers