Delving into the Latest Updates on ZSP0678 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

PPAR

Mechanism

PPAR agonists(Peroxisome proliferator activated receptor agonists)

Therapeutic Areas

Digestive System DisordersOther Diseases

Active Indication

Primary Biliary CholangitisFamilial Primary Biliary Cirrhosis

Inactive Indication

Nonalcoholic Steatohepatitis

Originator Organization

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

Active Organization

Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP0678 or placebo .

Start Date19 Nov 2019

Sponsor / Collaborator

Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.

CTR20191375 / CompletedPhase 1

随机、双盲、安慰剂对照的剂量递增I期试验，评价ZSP0678片在成人健康受试者的安全性、耐受性、药代动力学

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase I trial to evaluate the safety, tolerability, and pharmacokinetics of ZSP0678 tablets in healthy adult subjects

评价ZSP0678片单次/多次口服给药后在成人健康受试者的安全性、耐受性和药代动力学特性及食物影响。

[Translation]

To evaluate the safety, tolerability, pharmacokinetic properties and food effects of ZSP0678 tablets in healthy adult subjects after single/multiple oral administration.

Start Date13 Nov 2019

Sponsor / Collaborator

Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.

100 Clinical Results associated with ZSP0678

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100 Translational Medicine associated with ZSP0678

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100 Patents (Medical) associated with ZSP0678

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100 Deals associated with ZSP0678

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	CN	Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.	13 Nov 2019
Primary Biliary Cholangitis	Phase 2	CN	Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.	-
Familial Primary Biliary Cirrhosis	Phase 1	CN	Guangdong Zhongsheng Ruichuang Biotechnology Co. Ltd.	30 Jan 2022