The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

NCT02889822 | Completed Phase 1

• 1 other identifier: SN-YQ-2010003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Safety assessment of Alprostadil Liposome for Injection

  The safety assessment for this study include: 1. Adverse event（AEs） 2. Change from baseline in physical examination,vital signs,laboratory examinations 3. Local irritation symptoms

  14 days

Study Arms (1)

Alprostadil Liposomes for Injection

EXPERIMENTAL

1. Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd 2. Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.

Drug: Alprostadil Liposomes for Injection

Interventions

Alprostadil Liposomes for Injection DRUG

1. Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd 2. Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.

Alprostadil Liposomes for Injection

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers are at least 20 years of age and no older than 40.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

The Affiliated Hospital of Academy of Military Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zeyuan Liu

  The Affiliated Hospital of Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 13, 2016

Record last verified: 2016-08

Locations

CN (1)