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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669562
Recruitment Status : Unknown
Verified September 2018 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date September 13, 2018
Actual Study Start Date  ICMJE August 7, 2018
Estimated Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Official Title  ICMJE The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lower Extremity Arterial Occlusive Diseases
Intervention  ICMJE
  • Drug: Alprostadil Liposome for Injection
    intravenous infusion Alprostadil Liposome
  • Drug: Placebo
    intravenous infusion liposome control
Study Arms  ICMJE
  • Experimental: Alprostadil liposome
    Intervention: Drug: Alprostadil Liposome for Injection
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2018
Estimated Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03669562
Other Study ID Numbers  ICMJE QLDE201801/PRO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP