Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

Phase 1

Completed

• Conditions: Coronary Heart Disease; Coagulation Disorder
• Interventions: Drug: Anfibatide

• Registration Number: NCT01588132
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-26
• Last Update Submitted: 2012-04-26
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple dose group 9	Anfibatide	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
Multiple dose group 10	Anfibatide	Give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.
Single dose group 2	Anfibatide	Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers
Single dose gourp 1	Anfibatide	Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers
Single dose groups 3	Anfibatide	Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers
Single dose group 4	Anfibatide	Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers
Single dose group 6	Anfibatide	Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers
Single dose group 5	Anfibatide	Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers
Single dose group 7	Anfibatide	Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers
Single dose group 8	Anfibatide	Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers
Multiple dose group 11	Anfibatide	Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours

Primary Outcome Measures

Name	Time	Method
Safety endpoints	24 Hours	To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	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