Back to resultsThe Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Primary Purpose
Lower Extremity Arterial Occlusive Diseases
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Alprostadil Liposome for Injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lower Extremity Arterial Occlusive Diseases
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.
Sites / Locations
- Xuhuiqu central hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alprostadil liposome
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Secondary Outcome Measures
Full Information
NCT ID
NCT03669562
First Posted
August 21, 2018
Last Updated
September 11, 2018
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03669562
Brief Title
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Official Title
The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Arterial Occlusive Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alprostadil liposome
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alprostadil Liposome for Injection
Intervention Description
intravenous infusion Alprostadil Liposome
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous infusion liposome control
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yue Ying, Master
Phone
15931108221
Email
pengyueying@mail.ecspc.com
Facility Information:
Facility Name
Xuhuiqu central hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chen, bachelor
12. IPD Sharing Statement
Learn more about this trial
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
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