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

NCT ID: NCT03669562

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2018-10-30

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.

Conditions

Lower Extremity Arterial Occlusive Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Alprostadil liposome

Group Type: EXPERIMENTAL

Alprostadil Liposome for Injection

Intervention Type: DRUG

intravenous infusion Alprostadil Liposome

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

intravenous infusion liposome control

Interventions

Alprostadil Liposome for Injection

intravenous infusion Alprostadil Liposome

Intervention Type: DRUG

Placebo

intravenous infusion liposome control

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuhuiqu central hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Yue Ying, Master

Role: CONTACT

pengyueying@mail.ecspc.com

15931108221

Facility Contacts

Yu Chen, bachelor

Role: primary

Other Identifiers

QLDE201801/PRO

Identifier Type: -

Identifier Source: org_study_id