Clinical trial NCT01588132: Anfibatide Phase 1 Clinical Trial in Healthy Volunteers
Official title: First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Heart Disease
Coagulation Disorder
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety endpoints
timeFrame: 24 Hours
Secondary outcomes:
measure: Area Under Curve (AUC)
timeFrame: Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours
Other outcomes:
Locations:
Study officials:
References:
citation: 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.