Antiplatelet DrugPhase 1NCT04404790

Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers

A Phase 1 study testing Anfibatide 5 IU/60kg, Anfibatide 5 IU/60kg +0.002 IU/kg/h and Anfibatide 5 IU/60kg +0.004 IU/kg/h in people with Antiplatelet Drug, run by Lee's Pharmaceutical Limited at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Antiplatelet Drug
What is being tested?: Anfibatide 5 IU/60kg, Anfibatide 5 IU/60kg +0.002 IU/kg/h and Anfibatide 5 IU/60kg +0.004 IU/kg/h
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: Sep 2020to May 2021
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

Male or female healthy subjects between the ages of 18 to 40 years（including）.
The body mass index（BMI）， in the range of 19 ~ 24 (including).
Medical history without heart, liver, kidney, digestive tract, nervous system, metabolic, ulcer, obvious bleeding, and history of drug allergy or postural hypotension.
According to the medical history, physical examination, vital signs, chest radiograph, 12-lead ECG, coagulation routine, stool routine and occult blood test, as well as the laboratory results of blood and urine, the subjects are healthy.
The subjects do not take any medicine in the past two weeks.
Willingness to participate the study and sign the written Informed Consent Form.
Non-lactating women willingness to use adequate contraceptive measures (including abstinence, intrauterine device, diaphragm and spermicide) during the study (screening period to 1 week after administration). Men are willing to use approved methods of contraception (including condoms and spermicides or oral, implanted or injectable contraceptives by their partners, intrauterine device, diaphragms and spermicides). Subjects do not plan to donate sperm or eggs within two weeks after drug administration.

Who cannot join

Abnormal with the safety evaluation is considered to be clinical significance in screening period as judged by the researcher.
Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis virus infection;
Excessive smoking (>5 cigarettes/day) or do not interrupt smoke during the study.
Intake of more than 25g of alcohol per day (equivalent to 750 mL of beer or 250 mL of wine, or 75 mL of white wine of 38 °, or 50 mL of white wine of ≥40 ° ). Subject who are positive for alcohol breath test or cannot stop drinking during the study.
Women with pregnant, lactating or menstruating.
History of previous hemoptysis, blood stool, skin mucosal bleeding points, etc., or bleeding tendency (patients with gingival, nasal, skin, mucosal bleeding, hemoptysis).

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History of active bleeding (peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc.).
The examination show arteriovenous malformation, hemangioma and other vascular abnormalities.
The examination show that there is hemorrhage in the fundus.
The platelet count is less than 150×109/L.
History of trauma (craniocerebral trauma, etc.) within 1 year.
History of unexplained syncope or convulsions.
History of autoimmune diseases, such as systemic lupus erythematosus.
History of organic or mental illnesses or disabilities.
According to the judgment by the researchers, subjects with low possibility of enrollment (such as weak body, etc.).
Donation of blood in the last 3 months or participation in other clinical trials in the last 3 months.
Previously recruited into other clinical studies of the product.
Mental, psychological, or language disorders that prevent understanding or cooperation.
Unwilling or unable to comply with the study schedule or procedure.
Unfit to participate in the study for any other reason.

Trial locations and contacts

1 site in 1 country.

China1 site

Bengbu Medical College First Hospital
Bengbu, Anhui, 233004

Other trials in China

About this study

Official title: Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer

This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.

Conditions: Antiplatelet Drug
Being tested: Anfibatide 5 IU/60kg, Anfibatide 5 IU/60kg +0.002 IU/kg/h, Anfibatide 5 IU/60kg +0.004 IU/kg/h, Anfibatide 5 IU/60kg +0.008 IU/kg/h, Anfibatide 7 IU/60kg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anfibatide 5 IU/60kgDrug
5 IU/60kg IV administration of Anfibatide with 5 minutes
Anfibatide 5 IU/60kg +0.002 IU/kg/hDrug
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
Anfibatide 5 IU/60kg +0.004 IU/kg/hDrug
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
Anfibatide 5 IU/60kg +0.008 IU/kg/hDrug
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours
Anfibatide 7 IU/60kgDrug
7 IU/60kg IV administration of Anfibatide with 5 minutes
Anfibatide 7 IU/60kg +0.002 IU/kg/hDrug
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
Anfibatide 7 IU/60kg +0.004 IU/kg/hDrug
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
Anfibatide 7 IU/60kg +0.008 IU/kg/hDrug
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Study groups in NCT04404790
Study group	Role	What they receive
Anfibatide 5 IU/60kg	Experimental	Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes. Receives: Drug: Anfibatide 5 IU/60kg
Anfibatide 5 IU/60kg+0.002 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 5 IU/60kg +0.002 IU/kg/h
Anfibatide 5 IU/60kg+0.004 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 5 IU/60kg +0.004 IU/kg/h
Anfibatide 5 IU/60kg+0.008 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 5 IU/60kg +0.008 IU/kg/h
Anfibatide 7 IU/60kg	Experimental	Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes. Receives: Drug: Anfibatide 7 IU/60kg
Anfibatide 7 IU/60kg+0.002 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 7 IU/60kg +0.002 IU/kg/h
Anfibatide 7 IU/60kg+0.004 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 7 IU/60kg +0.004 IU/kg/h
Anfibatide 7 IU/60kg+0.008 IU/kg/h	Experimental	Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours. Receives: Drug: Anfibatide 7 IU/60kg +0.008 IU/kg/h

What is being measured

The primary outcome is the main question the study is designed to answer.

Bleeding events
Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.
Measured: 7 days after drug administration

Secondary outcomes (7)

Cmax
Peak concentration
Measured: 7 days after drug administration
Tmax
Peak time
Measured: 7 days after drug administration
AUC(0-t)
Area under curve 0-t
Measured: 7 days after drug administration
AUC(0-∞)
Area under curve 0-∞
Measured: 7 days after drug administration
T1/2
Half life
Measured: 7 days after drug administration
Inhibition of platelet aggregation
Inhibition rate of platelet aggregation is measured by chrono-log700.
Measured: 7 days after drug administration
corrected QT interval
Corrected QT interval is measured by 12-lead ECG.
Measured: 7 days after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2020May 2021

First posted28 May 2020
Study startSep 2020 (estimated)
Primary completionMar 2021 (estimated)
Study completionMay 2021 (estimated)

Why it stopped: Optimization of protocol

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Antiplatelet DrugStudies of the same condition, open and under way.
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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04404790
Sponsor's protocol ID: ZK-APT-201803
Status last verified: May 2020
First submitted: 26 May 2020
Last updated: 28 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Antiplatelet Drug trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer
ClinicalTrials.gov ID: NCT04404790
Acronym / sponsor ID: ZK-APT-201803
Conditions: Antiplatelet Drug
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: Optimization of protocol
Enrolment: 50 participants (estimated)
Lead sponsor: Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
Study start: Sep 2020 (estimated)
Primary completion: Mar 2021 (estimated)
Study completion: May 2021 (estimated)
First posted: 28 May 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Anfibatide 5 IU/60kg	Experimental	Drug: Anfibatide 5 IU/60kgTen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.
Anfibatide 5 IU/60kg+0.002 IU/kg/h	Experimental	Drug: Anfibatide 5 IU/60kg +0.002 IU/kg/hFour or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
Anfibatide 5 IU/60kg+0.004 IU/kg/h	Experimental	Drug: Anfibatide 5 IU/60kg +0.004 IU/kg/hFour or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
Anfibatide 5 IU/60kg+0.008 IU/kg/h	Experimental	Drug: Anfibatide 5 IU/60kg +0.008 IU/kg/hFour or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.
Anfibatide 7 IU/60kg	Experimental	Drug: Anfibatide 7 IU/60kgTen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.
Anfibatide 7 IU/60kg+0.002 IU/kg/h	Experimental	Drug: Anfibatide 7 IU/60kg +0.002 IU/kg/hFour or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
Anfibatide 7 IU/60kg+0.004 IU/kg/h	Experimental	Drug: Anfibatide 7 IU/60kg +0.004 IU/kg/hFour or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
Anfibatide 7 IU/60kg+0.008 IU/kg/h	Experimental	Drug: Anfibatide 7 IU/60kg +0.008 IU/kg/hFour or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female healthy subjects between the ages of 18 to 40 years（including）.
The body mass index（BMI）， in the range of 19 ~ 24 (including).
Medical history without heart, liver, kidney, digestive tract, nervous system, metabolic, ulcer, obvious bleeding, and history of drug allergy or postural hypotension.
According to the medical history, physical examination, vital signs, chest radiograph, 12-lead ECG, coagulation routine, stool routine and occult blood test, as well as the laboratory results of blood and urine, the subjects are healthy.
The subjects do not take any medicine in the past two weeks.

Key exclusion criteria (20 listed)

Abnormal with the safety evaluation is considered to be clinical significance in screening period as judged by the researcher.
Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis virus infection;
Excessive smoking (>5 cigarettes/day) or do not interrupt smoke during the study.
Intake of more than 25g of alcohol per day (equivalent to 750 mL of beer or 250 mL of wine, or 75 mL of white wine of 38 °, or 50 mL of white wine of ≥40 ° ). Subject who are positive for alcohol breath test or cannot stop drinking during the study.
Women with pregnant, lactating or menstruating.

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
Anfibatide 5 IU/60kg5 IU/60kg IV administration of Anfibatide with 5 minutes	Drug	Anfibatide 5 IU/60kg
Anfibatide 5 IU/60kg +0.002 IU/kg/h5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 5 IU/60kg+0.002 IU/kg/h
Anfibatide 5 IU/60kg +0.004 IU/kg/h5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 5 IU/60kg+0.004 IU/kg/h
Anfibatide 5 IU/60kg +0.008 IU/kg/h5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 5 IU/60kg+0.008 IU/kg/h
Anfibatide 7 IU/60kg7 IU/60kg IV administration of Anfibatide with 5 minutes	Drug	Anfibatide 7 IU/60kg
Anfibatide 7 IU/60kg +0.002 IU/kg/h7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 7 IU/60kg+0.002 IU/kg/h
Anfibatide 7 IU/60kg +0.004 IU/kg/h7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 7 IU/60kg+0.004 IU/kg/h
Anfibatide 7 IU/60kg +0.008 IU/kg/h7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours	Drug	Anfibatide 7 IU/60kg+0.008 IU/kg/h

Primary outcome

Bleeding events
Time frame: 7 days after drug administration
Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.

7 secondary outcomes

Cmax
Time frame: 7 days after drug administration
Tmax
Time frame: 7 days after drug administration
AUC(0-t)
Time frame: 7 days after drug administration
AUC(0-∞)
Time frame: 7 days after drug administration
T1/2
Time frame: 7 days after drug administration
Inhibition of platelet aggregation
Time frame: 7 days after drug administration
corrected QT interval
Time frame: 7 days after drug administration

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.

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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.

Ningru Zhang study director

Bengbu Medical College First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 20 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: paused, as of the sponsor's last update on 28 May 2020. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding events (time frame: 7 days after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04404790.

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 28 May 2020.