[Translation] A single-center, randomized, open-label, parallel-controlled phase I clinical study comparing the pharmacokinetic characteristics, safety and immunogenicity of recombinant glucagon-like peptide-1-Fc fusion protein injection (SAL015) and dulaglutide injection (Duida®) in healthy Chinese male subjects

主要目的：比较SAL015和度易达®在中国健康男性受试者中单次皮下注射后药代动力学特征的相似性。次要目的：比较SAL015和度易达®在中国健康男性受试者中单次皮下注射后安全性和免疫原性的相似性。

[Translation]

Primary objective: To compare the similarity of pharmacokinetic characteristics of SAL015 and Duyida® in healthy Chinese male subjects after a single subcutaneous injection. Secondary objective: To compare the similarity of safety and immunogenicity of SAL015 and Duyida® in healthy Chinese male subjects after a single subcutaneous injection.

Start Date06 Nov 2020

Sponsor / Collaborator

Genekey Biotech (Chengdu) Co. Ltd.

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100 Clinical Results associated with Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

100 Translational Medicine associated with Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

100 Patents (Medical) associated with Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

Literatures (Medical) associated with Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

01 Jan 2007·Gene TherapyQ3 · MEDICINE

Gene therapy of diabetes using a novel GLP-1/IgG1-Fc fusion construct normalizes glucose levels in db/db mice

Q3 · MEDICINE

Article

Author: Y Glinka ; Y Hunag ; M Kumar ; Q Wang ; G J Prud'Homme

Glucagon-like peptide (GLP-1), a major physiological incretin, plays numerous important roles in modulating blood glucose homeostasis and has been proposed for the treatment of type 2 diabetes. The major obstacles for using native GLP-1 as a therapeutic agent are that it must be delivered by a parenteral route and has a short half-life. In an attempt to develop a strategy to prolong the physiological t(1/2) and enhance the potency of GLP-1, a fusion protein consisting of active human GLP-1 and mouse IgG(1) heavy chain constant regions (GLP-1/Fc) was generated. A plasmid encoding an IgK leader peptide-driven secretable fusion protein of the active GLP-1 and IgG(1)-Fc was constructed for mammalian expression. This plasmid allows for expression of bivalent GLP-1 peptide ligands as a result of IgG-Fc homodimerization. In vitro studies employing purified GLP-1/Fc indicate that the fusion protein is functional and elevates cAMP levels in insulin-secreting INS-1 cells. In addition, it stimulates insulin secretion in a glucose concentration-dependent manner. Intramuscular gene transfer of the plasmid in db/db mice demonstrated that expression of the GLP-1/Fc peptide normalizes glucose tolerance by enhancing insulin secretion and suppressing glucagon release. This strategy of using a bivalent GLP-1/Fc fusion protein as a therapeutic agent is a novel approach for the treatment of diabetes.

100 Deals associated with Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 3	CN	Shenzhen Salubris Pharmaceuticals Co., Ltd.	21 Jul 2022
Diabetes Mellitus, Type 2	Preclinical	CN	Salubris (Suzhou) Pharmaceuticals Co., Ltd.	06 Nov 2020
Diabetes Mellitus, Type 2	Preclinical	CN	Genekey Biotech (Chengdu) Co. Ltd.	06 Nov 2020
Obesity	Preclinical	CN	Shenzhen Salubris Pharmaceuticals Co., Ltd.	04 Apr 2018

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Recombinant GLP-1-Fc fusion protein(Genekey Biotech (Chengdu) )

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