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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
1. Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd 2. Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.
The Affiliated Hospital of Academy of Military Medical Sciences
Beijing, China
Safety assessment of Alprostadil Liposome for Injection
The safety assessment for this study include: 1. Adverse event(AEs) 2. Change from baseline in physical examination,vital signs,laboratory examinations 3. Local irritation symptoms
Time frame: 14 days
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