NCT03669562UnknownPhase 1
The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country48 target enrollmentStarted: August 7, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers are at least 18 years of age and no older than
- •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.
Arms & Interventions
Alprostadil liposome
Experimental
Intervention: Alprostadil Liposome for Injection (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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