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

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

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

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

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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