The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

Study Overview
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Brief Summary
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Conducted in Chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

Official Title
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The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers

Conditions
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Lower Extremity Arterial Occlusive Diseases

Intervention / Treatment
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* Drug: Alprostadil Liposome for Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers are at least 18 years of age and no older than 40. BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The male weight is greater than or equal to 50kg.The female weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion. Subjects with normal medical history,vital signs,physical examination and clinical examination (routine blood,routine urine,blood chemistry,coagulation function and ECG,X-ray,intraocular pressure and so on). A negative hepatitis B surface antigen,hepatitis C,HIV or syphilis test result. Subjects with the ability to communicate with investigators.Besides,subjects must be willing to remain at the study center as required per protocal to complete all visit assessments. Exclusion Criteria: Subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators. Subjects with a history of psychiatric disease or drug dependence. Subjects with a medical history about cardiac,liver,renal,digestive system or neurological. Subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma. Subjects significantly abuse alcohol or tobacco. Drink in 24 hours before post-dosing of study drug. Subjects who had taken medications within 2 weeks. Subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded. Subjects who participate in other clinical trials within 3 months will be excluded. History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes. Subjects with a history of fainting. Subjects who had infected for unknown reason. Subjects with interstitial pneumonia. Subjects with glaucoma or intraocular pressure with hyperthyroidism. Women who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alprostadil liposome<br> | Drug: Alprostadil Liposome for Injection<br>* intravenous infusion Alprostadil Liposome<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* intravenous infusion liposome control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | 8 days |