The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and tolerability of single/multiple-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Alprostadil Liposomes for Injection

Detailed Description

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and tolerability of single/multiple-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

1. Single dosing tolerability test in humans.There are 7 dose (10ug,20ug,50ug,100ug,200ug,300ug,400ug) groups in the single dosing tolerance test in healthy adult volunteers.The beginning dose of the study is 10ug,according to the dose escalation method,subjects who have successfully completed previous dose group and passed the safety assessment will enter the test of next dose group with the same method.
2. Multiple dosing tolerability test in humans.Choose the proper dosage for multiple dosing tolerance test based on the single-dose tolerance test result.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The Affiliated Hospital of Academy of Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers are at least 20 years of age and no older than 40.
• BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion.
• Subjects with normal heart rate( 60-100 beats per minute) as well as normal blood pressure(systolic blood pressure:90-120 mmHg;diastolic blood pressure:60-90 mmHg).
• 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.
• Given their signed written informed consent to participate.

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 in the past 2 years.
• 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 200ml 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 were in the mentrual period.
• Women who are pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alprostadil Liposomes for Injection; Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd; Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.	Drug: Alprostadil Liposomes for Injection; Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd; Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment of Alprostadil Liposome for Injection	The safety assessment for this study include: Adverse event（AEs）; Change from baseline in physical examination,vital signs,laboratory examinations; Local irritation symptoms	14 days

Collaborators and Investigators

• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Investigators: Principal Investigator: Zeyuan Liu, The Affiliated Hospital of Academy of Military Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: SN-YQ-2010003