Delving into the Latest Updates on CS-060304 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

THR-β

Mechanism

THR-β agonists(Thyroid hormone receptor beta-1 agonists)

Therapeutic Areas

Digestive System DisordersEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

Hyper LDL cholesterolaemiaNonalcoholic SteatohepatitisHomozygous familial hypercholesterolemia

Inactive Indication-

Originator Organization

Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.

Active Organization

Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：考察健康和 LDL-C 升高受试者单次和多次口服 CS060304 的安全性和耐受性次要目的：考察健康和 LDL-C 升高受试者单次、多次以及食物对健康受试者单次口服 CS060304 的 PK特征探索性目的：单次或多次口服 CS060304 的药效动力学、对甲状腺功能的影响、对QT间期的影响

[Translation]

Primary objective: To investigate the safety and tolerability of single and multiple oral administration of CS060304 in healthy and LDL-C elevated subjects Secondary objective: To investigate the PK characteristics of single and multiple oral administration of CS060304 in healthy and LDL-C elevated subjects, as well as the effect of food on single oral administration of CS060304 in healthy subjects Exploratory objective: Pharmacodynamics of single or multiple oral administration of CS060304, effects on thyroid function, and effects on QT interval

Start Date-

Sponsor / Collaborator

Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.

NCT06485245 / Not yet recruitingPhase 1

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalations of CS060304 in Healthy and Elevated LDL-C Subjects

Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects.

Start Date14 Aug 2024

Sponsor / Collaborator

Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with CS-060304

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100 Translational Medicine associated with CS-060304

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100 Patents (Medical) associated with CS-060304

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100 Deals associated with CS-060304

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyper LDL cholesterolaemia	Phase 1	CN	Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.	14 Aug 2024
Nonalcoholic Steatohepatitis	Phase 1	CN	Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.	23 Jul 2024
Homozygous familial hypercholesterolemia	IND Approval	CN	Case Kaidi (Shanghai) Pharmaceutical Technology Co., Ltd.	25 Jul 2024