Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

Lee's Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Coronary Heart Disease; Coagulation Disorder

Treatments: Drug: Anfibatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588132

LeesPharm_Anfibatide_Phase1

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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94 participants in 11 patient groups

Single dose gourp 1

Experimental group

Description:

Anfibatide injection at the concentration of 0.33μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 2

Experimental group

Description:

Anfibatide injection at the concentration of 0.66μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose groups 3

Experimental group

Description:

Anfibatide injection at the concentration of1.0μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 4

Experimental group

Description:

Anfibatide injection at the concentration of 1.5μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 5

Experimental group

Description:

Anfibatide injection at the concentration of 2.0μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 6

Experimental group

Description:

Anfibatide injection at the concentration of 3.0μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 7

Experimental group

Description:

Anfibatide injection at the concentration of 4.0μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Single dose group 8

Experimental group

Description:

Anfibatide injection at the concentration of 5.0μg/60kg in healthy volunteers

Treatment:

Drug: Anfibatide

Multiple dose group 9

Experimental group

Description:

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

Treatment:

Drug: Anfibatide

Multiple dose group 10

Experimental group

Description:

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

Treatment:

Drug: Anfibatide

Multiple dose group 11

Experimental group

Description:

Give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours

Treatment:

Drug: Anfibatide