The Safety and Tolerability of Alprostadil Liposome for I... | NCT03669562

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

NCT03669562

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 13, 2018Actual

Enrollment

48Estimated

Phase

Phase 1

Conditions

Lower Extremity Arterial Occlusive Diseases

Interventions

Alprostadil Liposome for Injection
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2018Actual

Primary Completion Date

Oct 15, 2018Estimated

Completion Date

Oct 30, 2018Estimated

First Submitted Date

Aug 21, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2018

Last Update Posted Date

Sep 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Label	Type	Description	Intervention Names
Alprostadil liposome	Experimental		Drug: Alprostadil Liposome for Injection
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Alprostadil Liposome for Injection	Drug	intravenous infusion Alprostadil Liposome	Alprostadil liposome

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	8 days

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics