[Translation] A randomized, double-blind, placebo-controlled safety, efficacy, and pharmacokinetics trial of SIPI-7623 tablets in subjects with hyperlipidemia

主要目的：探索高血脂受试者多次给予SIPI-7623片后的安全性。次要目的：探索高血脂受试者多次给予SIPI-7623片后的药代动力学特征和药物效应，为II期临床试验方案制定提供依据。

[Translation]

Primary purpose: To explore the safety of hyperlipidemic subjects after multiple administration of SIPI-7623 tablets. Secondary purpose: To explore the pharmacokinetic characteristics and drug effects of hyperlipidemic subjects after multiple administration of SIPI-7623 tablets, and to provide a basis for the formulation of Phase II clinical trial plan.

Start Date07 Oct 2019

Sponsor / Collaborator

Shanghai Institute of Pharmaceutical Industry

[+1]

CTR20182217 / SuspendedPhase 1

SIPI-7623片在健康受试者中随机双盲、安慰剂对照、单剂量耐受性、进食影响与药代动力学临床试验

[Translation] A randomized, double-blind, placebo-controlled, single-dose clinical trial of SIPI-7623 tablets in healthy subjects to evaluate tolerance, effect of food intake, and pharmacokinetics

评价SIPI-7623片单次给药在健康受试者中的安全性、耐受性、食物影响以及药代动力学特征。

[Translation]

To evaluate the safety, tolerability, food effect, and pharmacokinetic characteristics of a single dose of SIPI-7623 tablets in healthy subjects.

Start Date21 Feb 2019

Sponsor / Collaborator

Shanghai Institute of Pharmaceutical Industry

[+1]

100 Clinical Results associated with SIPI-7623

100 Translational Medicine associated with SIPI-7623

100 Patents (Medical) associated with SIPI-7623

Literatures (Medical) associated with SIPI-7623

01 Feb 2019·Molecular diversityQ3 · CHEMISTRY

Synthesis and biological evaluation of novel SIPI-7623 derivatives as farnesoid X receptor (FXR) antagonists

Q3 · CHEMISTRY

Article

Author: Jiang, Zheng-Li ; Tan, Xiang-Duan ; Nian, Si-Yun ; Wang, Guo-Ping ; Huang, Mo-Han ; Xiao, Ying ; Zhou, Yi-Huan

Most of reported steroidal FXR antagonists are restricted due to low potency. We described the design and synthesis of novel nonsteroidal scaffold SIPI-7623 derivatives as FXR antagonists. The most potent compound A-11 (IC₅₀ = 7.8 ± 1.1 μM) showed better activity compared to SIPI-7623 (IC₅₀ = 40.8 ± 1.7 μM) and guggulsterone (IC₅₀ = 45.9 ± 1.1 μM). Docking of A-11 in FXR's ligand-binding domain was also studied.

100 Deals associated with SIPI-7623

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 1	CN	Jiangsu Carephar Pharmaceutical Co., Ltd.	26 Sep 2021
Hyperlipidemia, Familial Combined	Phase 1	CN	Shanghai Institute of Pharmaceutical Industry	21 Feb 2019
Hyperlipidemia, Familial Combined	Phase 1	CN	Nanjing Carephar Pharmaceutical Co., Ltd.	21 Feb 2019

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