Lower Extremity Arterial Occlusive DiseasesPhase 1NCT03669562
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
A Phase 1 study testing Alprostadil Liposome for Injection in people with Lower Extremity Arterial Occlusive Diseases, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Arterial Occlusive Diseases
- What is being tested?
- Alprostadil Liposome for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2018to 30 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuhuiqu central hospital
Shanghai, Shanghai Municipality
Yu Chen, bachelor
About this study
Official title: 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.
- Being tested
- Alprostadil Liposome for Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil Liposome for InjectionDrug
intravenous infusion Alprostadil Liposome
PlaceboDrug
intravenous infusion liposome control
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil liposome | Experimental | Not described Receives: Drug: Alprostadil Liposome for Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start7 Aug 2018
- Primary completion15 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669562
- Sponsor's protocol ID
- QLDE201801/PRO
- Status last verified
- Sep 2018
- First submitted
- 21 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03669562
- Acronym / sponsor ID
- QLDE201801/PRO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil liposome | Experimental | Drug: Alprostadil Liposome for Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprostadil Liposome for Injectionintravenous infusion Alprostadil Liposome | Drug | Alprostadil liposome |
| Placebointravenous infusion liposome control | Drug | Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprostadil Liposome for Injection in people with Lower Extremity Arterial Occlusive Diseases, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Yue Ying, Master (15931108221, pengyueying@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.