Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03669562
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lower Extremity Arterial Occlusive Diseases Drug: Alprostadil Liposome for Injection Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arm Intervention/treatment
Experimental: Alprostadil liposome Drug: Alprostadil Liposome for Injection
intravenous infusion Alprostadil Liposome

Placebo Comparator: Placebo Drug: Placebo
intravenous infusion liposome control




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669562


Contacts
Layout table for location contacts
Contact: Peng Yue Ying, Master 15931108221 pengyueying@mail.ecspc.com

Locations
Layout table for location information
China, Shanghai
Xuhuiqu central hospital Recruiting
Shanghai, Shanghai, China
Contact: Yu Chen, bachelor         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Layout table for additonal information
Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03669562     History of Changes
Other Study ID Numbers: QLDE201801/PRO
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents