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1. To investigate the tolerability and safety of different doses of recombinant new hirudin (yeast) for injection in the treatment of NSTE-ACS; 2. To explore the pharmacokinetic and pharmacodynamic characteristics of different doses of recombinant new hirudin (yeast) for injection in the treatment of NSTE-ACS;

Start Date15 Oct 2021

Sponsor / Collaborator

Beijing Sanyouli Heze Biological Technology Co. Ltd.

[+1]

CTR20160444

/ CompletedPhase 1

评价注射用重组新蛭素（酵母）单次和多次给药在健康志愿者中的安全性、耐受性和药代动力学临床试验

[Translation] Clinical trial to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of recombinant hirudin (yeast) for injection in healthy volunteers

本试验的目的是为了评价注射用重组新蛭素（酵母）在健康受试者中的单次和多次给药的耐受性以及药代动力学指标，为制定后续II期临床试验的给药方案提供安全的剂量范围。

[Translation]

The purpose of this study is to evaluate the tolerability and pharmacokinetic parameters of single and multiple administrations of recombinant hirudin (yeast) for injection in healthy subjects, and to provide a safe dosage range for the formulation of dosing regimens for subsequent Phase II clinical trials.

Start Date26 Jul 2016

Sponsor / Collaborator

Beijing Sanyouli Heze Biological Technology Co. Ltd.

[+1]

100 Clinical Results associated with EH(Beijing SH Bio-Tech)

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100 Translational Medicine associated with EH(Beijing SH Bio-Tech)

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100 Patents (Medical) associated with EH(Beijing SH Bio-Tech)

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100 Deals associated with EH(Beijing SH Bio-Tech)

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Indication	Highest Phase	Country/Location	Organization	Date
Non ST segment elevation acute coronary syndrome	Phase 1	China	Beijing Sanyouli Heze Biological Technology Co. Ltd.	15 Oct 2021
Non ST segment elevation acute coronary syndrome	Phase 1	China	Chinese People's Liberation Army General Hospital	15 Oct 2021
Venous Thromboembolism	Phase 1	China	Beijing Sanyouli Heze Biological Technology Co. Ltd.	26 Jul 2016
Venous Thromboembolism	Phase 1	China	Chinese People's Liberation Army General Hospital	26 Jul 2016
Venous Thrombosis	IND Application	China	Beijing Sanyouli Heze Biological Technology Co. Ltd.	15 Oct 2013
Venous Thrombosis	IND Application	China	Academy of Military Medical Sciences	15 Oct 2013

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