- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669562
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
September 11, 2018 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peng Yue Ying, Master
- Phone Number: 15931108221
- Email: pengyueying@mail.ecspc.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Xuhuiqu central hospital
-
Contact:
- Yu Chen, bachelor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
intravenous infusion liposome control
|
Experimental: Alprostadil liposome
|
intravenous infusion Alprostadil Liposome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 8 days
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Anticipated)
October 15, 2018
Study Completion (Anticipated)
October 30, 2018
Study Registration Dates
First Submitted
August 21, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLDE201801/PRO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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