The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Phase 1
- Conditions
- Lower Extremity Arterial Occlusive Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT03669562
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alprostadil liposome Alprostadil Liposome for Injection - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xuhuiqu central hospital
🇨🇳Shanghai, Shanghai, China