The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alprostadil liposome
|
Drug: Alprostadil Liposome for Injection
intravenous infusion Alprostadil Liposome
|
| Placebo Comparator: Placebo
|
Drug: Placebo
intravenous infusion liposome control
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [8 days]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy volunteers are at least 18 years of age and no older than 40.
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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.
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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).
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A negative hepatitis B surface antigen,hepatitis C,HIV or syphilis test result.
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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:
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Subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators.
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Subjects with a history of psychiatric disease or drug dependence.
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Subjects with a medical history about cardiac,liver,renal,digestive system or neurological.
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Subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma.
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Subjects significantly abuse alcohol or tobacco.
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Drink in 24 hours before post-dosing of study drug.
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Subjects who had taken medications within 2 weeks.
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Subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded.
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Subjects who participate in other clinical trials within 3 months will be excluded.
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History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
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Subjects with a history of fainting.
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Subjects who had infected for unknown reason.
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Subjects with interstitial pneumonia.
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Subjects with glaucoma or intraocular pressure with hyperthyroidism.
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Women who are pregnant or lactating.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xuhuiqu central hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLDE201801/PRO