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

Summary

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.

Conditions

• Antiplatelet Drug

Interventions

DRUG

Anfibatide 5 IU/60kg

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

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

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

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

DRUG

Anfibatide 7 IU/60kg

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

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

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

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

Sponsors & Collaborators

• Lee's Pharmaceutical Limited

  lead INDUSTRY

Principal Investigators

• Ningru Zhang · Bengbu Medical College First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-30

Primary Completion

2021-03-31

Completion

2021-05-31

Countries

• China

Study Locations