Delving into the Latest Updates on EH(Beijing SH Bio-Tech) with Synapse

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.

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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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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Venous Thromboembolism	Phase 2	CN	Chinese PLA Academy of Military Medical Sciences	26 Jul 2016
Venous Thromboembolism	Phase 2	CN	Beijing Sanyouli Heze Biological Technology Co. Ltd.	26 Jul 2016
Venous Thrombosis	Phase 2	CN	Academy of Military Medical Sciences	15 Oct 2013
Venous Thrombosis	Phase 2	CN	Beijing Sanyouli Heze Biological Technology Co. Ltd.	15 Oct 2013
Non ST segment elevation acute coronary syndrome	Phase 1	CN	Chinese PLA Academy of Military Medical Sciences	15 Oct 2021
Non ST segment elevation acute coronary syndrome	Phase 1	CN	Beijing Sanyouli Heze Biological Technology Co. Ltd.	15 Oct 2021