Delving into the Latest Updates on JL14001 with Synapse

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

Target

EPO receptor

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic DiseasesUrogenital Diseases

Active Indication

chronic renal failure anemia

Inactive Indication-

Originator Organization

Jecho Biopharmaceuticals Co., Ltd.

Active Organization

Jieku (Shanghai) Biomedical Research Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价JL14001注射液在健康成年受试者中的安全性、耐受性。次要目的：评价JL14001注射液在健康成年受试者中的药代动力学（PK）特征；初步评价JL14001注射液在健康成年受试者中的药效动力学（PD）特征；初步评价JL14001注射液在健康成年受试者中的免疫原性；初步评估短效EPO产品-益比奥及长效EPO产品-耐斯宝分别与JL14001注射液的剂量换算关系和PD特征。

[Translation]

Primary purpose: Evaluate the safety and tolerability of JL14001 injection in healthy adult subjects. Secondary purpose: Evaluate the pharmacokinetic (PK) characteristics of JL14001 injection in healthy adult subjects; Preliminary evaluation of the pharmacodynamic (PD) characteristics of JL14001 injection in healthy adult subjects; Preliminary evaluation of the immunogenicity of JL14001 injection in healthy adult subjects; Preliminary evaluation of the dose conversion relationship and PD characteristics of the short-acting EPO product - EPIAO and the long-acting EPO product - Nicebo with JL14001 injection respectively.

Start Date07 Apr 2023

Sponsor / Collaborator

Jieku (Shanghai) Biomedical Research Co., Ltd.

100 Clinical Results associated with JL14001

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100 Translational Medicine associated with JL14001

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100 Patents (Medical) associated with JL14001

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100 Deals associated with JL14001

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