Anfibatide Phase 1 Clinical Trial in Healthy Volunteers
Overview
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.
Full Title of Study: “First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: March 2011
Interventions
- Drug: Anfibatide
- 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.
Arms, Groups and Cohorts
- Experimental: Single dose gourp 1
- Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers
- Experimental: Single dose group 2
- Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers
- Experimental: Single dose groups 3
- Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers
- Experimental: Single dose group 4
- Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers
- Experimental: Single dose group 5
- Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers
- Experimental: Single dose group 6
- Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers
- Experimental: Single dose group 7
- Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers
- Experimental: Single dose group 8
- Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers
- Experimental: Multiple dose group 9
- 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
- Experimental: Multiple dose group 10
- Give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.
- Experimental: Multiple dose group 11
- Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours
Clinical Trial Outcome Measures
Primary Measures
- Safety endpoints
- Time Frame: 24 Hours
- To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet
Secondary Measures
- Area Under Curve (AUC)
- Time Frame: Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours
- To observe area under curve characteristics of Anfibatide in single or multiple dose groups
Participating in This Clinical Trial
Inclusion Criteria
- 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. Exclusion Criteria:
- 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; – 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 28 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Lee’s Pharmaceutical Limited
- Provider of Information About this Clinical Study
- Principal Investigator: Vivian Fung, Ph.D – Lee’s Pharmaceutical Limited
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