MedTrace Logo

Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

NCT01588132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2012-04-30

No results posted yet for this study

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

Interventions

DRUG

Anfibatide

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.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588132 on ClinicalTrials.gov