NCT02477449

Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers

A Phase I Dose Escalating Study Evaluating the Pharmacokinetics, Tolerability and Safety of Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	istaroxime	8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 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).
DRUG	9% Saline (NS)	infusion for 24 hours

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-22
• Last updated: 2025-08-13

Locations

1 site across 1 country: China