Delving into the Latest Updates on HEC-53856 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HEC 53856, HEC53856, NT-001

Target

HIF-PHs

Action

inhibitors

Mechanism

HIF-PHs inhibitors(Hypoxia-inducible factor prolyl hydroxylase inhibitors)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Anemia of renal disease

Inactive Indication

Kidney Failure, Chronic

Originator Organization

Sunshine Lake Pharma Co., Ltd.

Active Organization

Sunshine Lake Pharma Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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评估HEC53856片在非髓系恶性肿瘤化疗引起的贫血受试者中的疗效与安全性；观察HEC53856片在非髓系恶性肿瘤化疗引起的贫血受试者中的药代动力学特征；评估HEC53856片对非髓系恶性肿瘤化疗引起的贫血受试者药效学/临床疗效指标的影响，包括但不限于：促红细胞生成素、血红蛋白、网织红细胞、血管内皮生长因子、铁调素、铁代谢和血脂指标。

[Translation]

To evaluate the efficacy and safety of HEC53856 tablets in subjects with anemia caused by chemotherapy for non-myeloid malignancies; to observe the pharmacokinetic characteristics of HEC53856 tablets in subjects with anemia caused by chemotherapy for non-myeloid malignancies; to evaluate the effects of HEC53856 tablets on the pharmacodynamic/clinical efficacy indicators of subjects with anemia caused by chemotherapy for non-myeloid malignancies, including but not limited to: erythropoietin, hemoglobin, reticulocytes, vascular endothelial growth factor, hepcidin, iron metabolism and lipid indicators.

Start Date23 Nov 2023

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

CTR20220660

/ CompletedPhase 1

一项在健康受试者空腹状态下比较HEC53856（NT001）片与HEC53856（NT001）胶囊的药代动力学/药效学的单中心、单剂量、随机、开放、两周期、双交叉、I期临床试验

[Translation] A single-center, single-dose, randomized, open-label, two-period, double-crossover, phase I clinical trial comparing the pharmacokinetics/pharmacodynamics of HEC53856 (NT001) tablets and HEC53856 (NT001) capsules in healthy subjects under fasting conditions

主要研究目的：通过健康受试者在空腹状态下分别单次口服HEC53856（NT001）片（50mg，受试制剂）与HEC53856（NT001）胶囊（50mg，参比制剂）的研究，评估受试制剂与参比制剂的药代动力学特征及相对生物利用度。次要研究目的：评价健康受试者单次空腹口服HEC53856（NT001）片和HEC53856（NT001）胶囊后的药效学特征；评价健康受试者单次空腹口服HEC53856（NT001）片和HEC53856（NT001）胶囊后的安全性。

[Translation]

The main purpose of the study is to evaluate the pharmacokinetic characteristics and relative bioavailability of the test preparation and the reference preparation by taking a single oral dose of HEC53856 (NT001) tablets (50 mg, test preparation) and HEC53856 (NT001) capsules (50 mg, reference preparation) in healthy subjects on an empty stomach. The secondary purpose of the study is to evaluate the pharmacodynamic characteristics of HEC53856 (NT001) tablets and HEC53856 (NT001) capsules after a single oral dose in healthy subjects on an empty stomach; to evaluate the safety of HEC53856 (NT001) tablets and HEC53856 (NT001) capsules after a single oral dose in healthy subjects on an empty stomach.

Start Date29 Jun 2022

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

NCT04925661

/ CompletedPhase 1

Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.

Start Date04 Nov 2021

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

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100 Clinical Results associated with HEC-53856

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100 Translational Medicine associated with HEC-53856

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100 Patents (Medical) associated with HEC-53856

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100 Deals associated with HEC-53856