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

Phase 1

• Conditions: Lower Extremity Arterial Occlusive Diseases
• Interventions: Drug: Alprostadil Liposome for Injection; 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

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2018-08-21
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-13
• Primary Completion: 2018-10-15
• Study Completion: 2018-10-30

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

Trial Locations

Locations (1)

Xuhuiqu central hospital; 🇨🇳 Shanghai, Shanghai, China