Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function

NCT04116476

Mild and Moderate Hepatic Impairment

COMPLETED PHASE1

Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

NCT02982707

Thrombosis

COMPLETED PHASE1

A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

NCT01012284

Moderate Hepatic Impairment

COMPLETED PHASE1

A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

NCT06019936

Drug-Induced Liver Injury Cholestatic Liver Injury Mixed Liver Injury

UNKNOWN PHASE2

A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection

NCT05865574

Healthy Men

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antiplatelet Drug

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anfibatide 5 IU/60kg

Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.

Group Type EXPERIMENTAL

Anfibatide 5 IU/60kg

Intervention Type DRUG

5 IU/60kg IV administration of Anfibatide with 5 minutes

Anfibatide 5 IU/60kg+0.002 IU/kg/h

Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 5 IU/60kg +0.002 IU/kg/h

Intervention Type DRUG

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours

Anfibatide 5 IU/60kg+0.004 IU/kg/h

Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 5 IU/60kg +0.004 IU/kg/h

Intervention Type DRUG

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours

Anfibatide 5 IU/60kg+0.008 IU/kg/h

Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 5 IU/60kg +0.008 IU/kg/h

Intervention Type DRUG

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Anfibatide 7 IU/60kg

Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.

Group Type EXPERIMENTAL

Anfibatide 7 IU/60kg

Intervention Type DRUG

7 IU/60kg IV administration of Anfibatide with 5 minutes

Anfibatide 7 IU/60kg+0.002 IU/kg/h

Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 7 IU/60kg +0.002 IU/kg/h

Intervention Type DRUG

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours

Anfibatide 7 IU/60kg+0.004 IU/kg/h

Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 7 IU/60kg +0.004 IU/kg/h

Intervention Type DRUG

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours

Anfibatide 7 IU/60kg+0.008 IU/kg/h

Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.

Group Type EXPERIMENTAL

Anfibatide 7 IU/60kg +0.008 IU/kg/h

Intervention Type DRUG

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anfibatide 5 IU/60kg

5 IU/60kg IV administration of Anfibatide with 5 minutes

Intervention Type DRUG

Anfibatide 5 IU/60kg +0.002 IU/kg/h

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Anfibatide 5 IU/60kg +0.004 IU/kg/h

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Anfibatide 5 IU/60kg +0.008 IU/kg/h

5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Anfibatide 7 IU/60kg

7 IU/60kg IV administration of Anfibatide with 5 minutes

Intervention Type DRUG

Anfibatide 7 IU/60kg +0.002 IU/kg/h

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Anfibatide 7 IU/60kg +0.004 IU/kg/h

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Anfibatide 7 IU/60kg +0.008 IU/kg/h

7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female healthy subjects between the ages of 18 to 40 years（including）.
2. The body mass index（BMI）， in the range of 19 \~ 24 (including).
3. Medical history without heart, liver, kidney, digestive tract, nervous system, metabolic, ulcer, obvious bleeding, and history of drug allergy or postural hypotension.
4. According to the medical history, physical examination, vital signs, chest radiograph, 12-lead ECG, coagulation routine, stool routine and occult blood test, as well as the laboratory results of blood and urine, the subjects are healthy.
5. The subjects do not take any medicine in the past two weeks.
6. Willingness to participate the study and sign the written Informed Consent Form.
7. Non-lactating women willingness to use adequate contraceptive measures (including abstinence, intrauterine device, diaphragm and spermicide) during the study (screening period to 1 week after administration). Men are willing to use approved methods of contraception (including condoms and spermicides or oral, implanted or injectable contraceptives by their partners, intrauterine device, diaphragms and spermicides). Subjects do not plan to donate sperm or eggs within two weeks after drug administration.

Exclusion Criteria

1. Abnormal with the safety evaluation is considered to be clinical significance in screening period as judged by the researcher.
2. Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis virus infection;
3. Excessive smoking (\>5 cigarettes/day) or do not interrupt smoke during the study.
4. Intake of more than 25g of alcohol per day (equivalent to 750 mL of beer or 250 mL of wine, or 75 mL of white wine of 38 °, or 50 mL of white wine of ≥40 ° ). Subject who are positive for alcohol breath test or cannot stop drinking during the study.
5. Women with pregnant, lactating or menstruating.
6. History of previous hemoptysis, blood stool, skin mucosal bleeding points, etc., or bleeding tendency (patients with gingival, nasal, skin, mucosal bleeding, hemoptysis).
7. History of active bleeding (peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc.).
8. The examination show arteriovenous malformation, hemangioma and other vascular abnormalities.
9. The examination show that there is hemorrhage in the fundus.
10. The platelet count is less than 150×109/L.
11. History of trauma (craniocerebral trauma, etc.) within 1 year.
12. History of unexplained syncope or convulsions.
13. History of autoimmune diseases, such as systemic lupus erythematosus.
14. History of organic or mental illnesses or disabilities.
15. According to the judgment by the researchers, subjects with low possibility of enrollment (such as weak body, etc.).
16. Donation of blood in the last 3 months or participation in other clinical trials in the last 3 months.
17. Previously recruited into other clinical studies of the product.
18. Mental, psychological, or language disorders that prevent understanding or cooperation.
19. Unwilling or unable to comply with the study schedule or procedure.
20. Unfit to participate in the study for any other reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes