Coronary Heart DiseasePhase 1NCT01588132
Anfibatide Phase 1 Clinical Trial in Healthy Volunteers
A Phase 1 study testing Anfibatide in people with Coronary Heart Disease and Coagulation Disorder, run by Lee's Pharmaceutical Limited.
Trial summary
In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Coagulation Disorder
- What is being tested?
- Anfibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 2011
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Healthy volunteers, aged 18-28 years, male and female were included, age difference less than 10 years;
- 2) Body weight: with body mass index (BMI) between 19-24, difference less than 10kg in the same group, BMI=body weight(kg)/height2;
- 3) Past medical history: no history of heart, liver, kidney, digestive tract, nervous system and metabolic disorder, or ulcer, significant hemorrhage, without the history of drug allergy and postural hypotension;
- 4) Medical examinations: with normal results in overall examinations (including heart rate, blood pressure, auscultation of heart and lung, palpation of liver and spleen, hepatic and renal function, hematology, coagulation function, urine analysis, stool analysis and occult blood test, electrocardiogram);
- 5) Have not received any medications within 2 weeks before the study;
- 6) Willing to participate in the study and give a signed informed consent form after understanding the study procedures and potential adverse reactions of the study product.
Who cannot join
- 1) History of HBV or HCV infection;
- 2) Addicted to smoking or alcohol;
- 3) Women during pregnancy, lactation or menstrual period;
- 4) Past history of hemoptysis, bloody stool, bleeding spots in the skin and mucous membrane, or hemorrhagic tendency (find themselves prone to bleeding in gums, nose, skin and mucous membrane, or hemoptysis);
- 5) History of active bleeding (such as peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc);
- 6) Blood platelet count less than 150×109;
Show all 11Show fewer
- 7) Trauma history (e.g., craniocerebral trauma) recently;
- 8) Past history of unexplained syncope or convulsion;
- 9) History of organic or psychogenic disease or the disabled;
- 10) Persons who were unlikely to participate in the study (such as the infirm) in the investigator's opinion;
- 11) Have donated blood or experienced blood collection in other trials within 3 months.
About this study
Official title: First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers
In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.
- Conditions
- Coronary Heart Disease, Coagulation Disorder
- Being tested
- Anfibatide
- Medical subject headings
- Coronary Disease, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnfibatideDrug
- To investigate the safety and tolerability of single intravenous dose of Antiplatelet Thrombolysin for Injection of 0.33,0.66,1.0,1.5,2.0,3.0,4.0,5.0μg (body weight 60kg) in healthy volunteers.
- To investigate the safety and tolerability of continuous administration of three dose regimen: ① give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours. ② give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. ③ give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Single dose gourp 1 | Experimental | Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 2 | Experimental | Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose groups 3 | Experimental | Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 4 | Experimental | Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 5 | Experimental | Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 6 | Experimental | Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 7 | Experimental | Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Single dose group 8 | Experimental | Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers Receives: Drug: Anfibatide |
| Multiple dose group 9 | Experimental | Give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours Receives: Drug: Anfibatide |
| Multiple dose group 10 | Experimental | Give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. Receives: Drug: Anfibatide |
| Multiple dose group 11 | Experimental | Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours Receives: Drug: Anfibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints
To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet
Measured: 24 Hours
Secondary outcomes (1)
Area Under Curve (AUC)
To observe area under curve characteristics of Anfibatide in single or multiple dose groups
Measured: Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Vivian Fung, Lee's Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588132
- Sponsor's protocol ID
- LeesPharm_Anfibatide_Phase1
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2012
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Li BX, Dai X, Xu XR, Adili R, Neves MAD, Lei X, Shen C, Zhu G, Wang Y, Zhou H, Hou Y, Ni T, Pasman Y, Yang Z, Qian F, Zhao Y, Gao Y, Liu J, Teng M, Marshall AH, Cerenzia EG, Li ML, Ni H. In vitro assessment and phase I randomized clinical trial of anfibatide a snake venom derived anti-thrombotic agent targeting human platelet GPIbalpha. Sci Rep. 2021 Jun 3;11(1):11663. doi: 10.1038/s41598-021-91165-8.
PubMed 34083615
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT01588132
- Acronym / sponsor ID
- LeesPharm_Anfibatide_Phase1
- Conditions
- Coronary Heart Disease, Coagulation Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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.
In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Single dose gourp 1 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers |
| Single dose group 2 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers |
| Single dose groups 3 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of1.0μg/60kg in healthy volunteers |
| Single dose group 4 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers |
| Single dose group 5 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers |
| Single dose group 6 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers |
| Single dose group 7 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers |
| Single dose group 8 | Experimental | Drug: AnfibatideAnfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers |
| Multiple dose group 9 | Experimental | Drug: AnfibatideGive intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours |
| Multiple dose group 10 | Experimental | Drug: AnfibatideGive intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. |
| Multiple dose group 11 | Experimental | Drug: AnfibatideGive intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1) Healthy volunteers, aged 18-28 years, male and female were included, age difference less than 10 years;
- 2) Body weight: with body mass index (BMI) between 19-24, difference less than 10kg in the same group, BMI=body weight(kg)/height2;
- 3) Past medical history: no history of heart, liver, kidney, digestive tract, nervous system and metabolic disorder, or ulcer, significant hemorrhage, without the history of drug allergy and postural hypotension;
- 4) Medical examinations: with normal results in overall examinations (including heart rate, blood pressure, auscultation of heart and lung, palpation of liver and spleen, hepatic and renal function, hematology, coagulation function, urine analysis, stool analysis and occult blood test, electrocardiogram);
- 5) Have not received any medications within 2 weeks before the study;
Key exclusion criteria (11 listed)
- 1) History of HBV or HCV infection;
- 2) Addicted to smoking or alcohol;
- 3) Women during pregnancy, lactation or menstrual period;
- 4) Past history of hemoptysis, bloody stool, bleeding spots in the skin and mucous membrane, or hemorrhagic tendency (find themselves prone to bleeding in gums, nose, skin and mucous membrane, or hemoptysis);
- 5) History of active bleeding (such as peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc);
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 |
|---|---|---|
| Anfibatide1. To investigate the safety and tolerability of single intravenous dose of Antiplatelet Thrombolysin for Injection of 0.33,0.66,1.0,1.5,2.0,3.0,4.0,5.0μg (body weight 60kg) in healthy volunteers. 2. To investigate the safety and tolerability of continuous administration of three dose regimen: ① give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours. ② give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. ③ give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. | Drug | Multiple dose group 10, Multiple dose group 11, Multiple dose group 9, Single dose gourp 1, Single dose group 2, Single dose group 4, Single dose group 5, Single dose group 6, Single dose group 7, Single dose group 8, Single dose groups 3 |
Primary outcome
Safety endpoints
Time frame: 24 Hours
To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet
1 secondary outcome
Area Under Curve (AUC)
Time frame: Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Derived from this study: PubMed 34083615Li BX, Dai X, Xu XR, Adili R, Neves MAD, Lei X, Shen C, Zhu G, Wang Y, Zhou H, Hou Y, Ni T, Pasman Y, Yang Z, Qian F, Zhao Y, Gao Y, Liu J, Teng M, Marshall AH, Cerenzia EG, Li ML, Ni H. In vitro assessment and phase I randomized clinical trial of anfibatide a snake venom derived anti-thrombotic agent targeting human platelet GPIbalpha. Sci Rep. 2021 Jun 3;11(1):11663. doi: 10.1038/s41598-021-91165-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anfibatide in people with Coronary Heart Disease and Coagulation Disorder, run by Lee's Pharmaceutical Limited.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety endpoints (time frame: 24 Hours). 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 NCT01588132, which also lists 1 linked publication.
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 30 Apr 2012.