Delving into the Latest Updates on 14028 with Synapse

Overview

Basic Info

Drug Type

Recombinant polypeptide, Biosimilar

Synonyms-

Target-

Mechanism-

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Diabetes Mellitus, Type 2

Originator Organization

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Active Organization-

Inactive Organization

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

Login to view timeline

To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Start Date31 May 2022

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

CTR20220954 / CompletedPhase 1

一项在健康受试者中比较14028注射液与度拉糖肽注射液（度易达®）药代动力学特征、安全性和免疫原性的单中心、随机、开放、单剂量、平行对照的I期临床研究

[Translation] A single-center, randomized, open-label, single-dose, parallel-controlled Phase I clinical study comparing the pharmacokinetic characteristics, safety, and immunogenicity of 14028 injection and dulaglutide injection (Duida®) in healthy subjects

以礼来公司在中国上市的度拉糖肽注射液（度易达®）为对照药品，评价单次皮下注射东莞市东阳光生物药研发有限公司提供的14028注射液在健康成年男性受试者中的药代动力学特点，并比较试验药物与对照药品的药代动力学相似性。

[Translation]

Using dulaglutide injection (Duida®) marketed in China by Eli Lilly as the control drug, the pharmacokinetic characteristics of a single subcutaneous injection of 14028 injection provided by Dongguan East Sunshine Biopharmaceutical R&D Co., Ltd. in healthy adult male subjects were evaluated, and the pharmacokinetic similarity of the test drug and the control drug was compared.

Start Date25 May 2022

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

100 Clinical Results associated with 14028

Login to view more data

100 Translational Medicine associated with 14028

Login to view more data

100 Patents (Medical) associated with 14028

Login to view more data

100 Deals associated with 14028

Login to view more data