Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

NCT01588132 | Completed Phase 1

• 1 other identifier: LeesPharm_Anfibatide_Phase1
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease; Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

• Safety endpoints

  To investigate the number of adverse events in patients with single or multiple intravenous injection/infusion of Antiplatelet

  24 Hours

Secondary Outcomes (1)

• Area Under Curve (AUC)

  Predose, 0,1,2,3,4,6,8,12,24,48,72,96 Hours

Study Arms (11)

Single dose gourp 1

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 2

EXPERIMENTAL

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

Drug: Anfibatide

Single dose groups 3

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 4

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 5

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 6

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 7

EXPERIMENTAL

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

Drug: Anfibatide

Single dose group 8

EXPERIMENTAL

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

Drug: Anfibatide

Multiple dose group 9

EXPERIMENTAL

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

Drug: Anfibatide

Multiple dose group 10

EXPERIMENTAL

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

Drug: Anfibatide

Multiple dose group 11

EXPERIMENTAL

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

Drug: Anfibatide

Interventions

Anfibatide DRUG

1. 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. 2. 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.

Multiple dose group 10; Multiple dose group 11; Multiple dose group 9; Single dose gourp 1; Single dose group 2; Single dose group 4; Single dose group 5; Single dose group 6; Single dose group 7; Single dose group 8; Single dose groups 3

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Healthy volunteers, aged 18-28 years, male and female were included, age difference less than 10 years;
• \) Body weight: with body mass index (BMI) between 19-24, difference less than 10kg in the same group, BMI=body weight(kg)/height2;
• \) 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;
• \) 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);
• \) Have not received any medications within 2 weeks before the study;
• \) 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.

You may not qualify if:

• \) History of HBV or HCV infection;
• \) Addicted to smoking or alcohol;
• \) Women during pregnancy, lactation or menstrual period;
• \) 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);
• \) History of active bleeding (such as peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc);
• \) Blood platelet count less than 150×109;
• \) Trauma history (e.g., craniocerebral trauma) recently;
• \) Past history of unexplained syncope or convulsion;
• \) History of organic or psychogenic disease or the disabled;
• \) Persons who were unlikely to participate in the study (such as the infirm) in the investigator's opinion;
• \) Have donated blood or experienced blood collection in other trials within 3 months.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Related Publications (1)

• 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.

  PMID: 34083615 DERIVED

MeSH Terms

Conditions

Coronary Disease; Hemostatic Disorders

Interventions

agkisacucetin protein, Agkistrodon acutus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 30, 2012
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 30, 2012

Record last verified: 2012-04