Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

Coronary Heart Disease Clinical Trial

Official title:

First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588132
• Other study ID #: LeesPharm_Anfibatide_Phase1
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2012
• Last updated: April 26, 2012
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 28 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Hemostatic Disorders
• Myocardial Ischemia

Intervention

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: ? 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. ? give intravenous injection of 3µg as the first dose and immediately infusion of the study product 0.12µg/h for 24 hours. ? give intravenous injection of 5µg as the first dose and immediately infusion of the study product 0.12µg/h for 24 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoints	To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet	24 Hours	Yes
Secondary	Area Under Curve (AUC)	To observe area under curve characteristics of Anfibatide in single or multiple dose groups	Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours	Yes