Cardiovascular Diseases Clinical Trial
Official title:
The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and tolerability of single/multiple-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.
Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and
tolerability of single/multiple-dose administration of different doses of Alprostadil
Liposome for Injection as well as to confirm the safety dose range.
1. Single dosing tolerability test in humans.There are 7 dose
(10ug,20ug,50ug,100ug,200ug,300ug,400ug) groups in the single dosing tolerance test in
healthy adult volunteers.The beginning dose of the study is 10ug,according to the dose
escalation method,subjects who have successfully completed previous dose group and
passed the safety assessment will enter the test of next dose group with the same
method.
2. Multiple dosing tolerability test in humans.Choose the proper dosage for multiple
dosing tolerance test based on the single-dose tolerance test result.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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