Delving into the Latest Updates on Quinolicin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DC-042, DC042

Target

α1A-AR

Action

antagonists

Mechanism

α1A-AR antagonists(Alpha-1a adrenergic receptor antagonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Prostatic Hyperplasia

Inactive Indication-

Originator Organization

Shanghai Institute of Materia Medica Chinese Academy of Sci

Active Organization

Jiangsu Kanion Pharmaceutical Co., Ltd.

Shanghai Institute of Materia Medica Chinese Academy of Sci

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Login to view timeline

主要目的：评价喹诺利辛片在良性前列腺增生患者中的6周国际前列腺症状评分（I-PSS）改善情况。次要目的：1.评价喹诺利辛片在良性前列腺增生患者中的有效性（I-PSS、最大尿流率Qmax、残余尿量、生活质量评分QOL的改善情况）；2.评价喹诺利辛片在良性前列腺增生患者中的安全性；3.评价喹诺利辛片在良性前列腺增生患者中的药代动力学（PK）特征。

[Translation]

Primary objective: To evaluate the improvement of the 6-week International Prostate Symptom Score (I-PSS) of Quinolicine Tablets in patients with BPH. Secondary objectives: 1. To evaluate the effectiveness of Quinolicine Tablets in patients with BPH (Improvement of I-PSS, maximum urine flow rate Qmax, residual urine volume, and quality of life score QOL); 2. To evaluate the safety of Quinolicine Tablets in patients with BPH; 3. To evaluate the pharmacokinetic (PK) characteristics of Quinolicine Tablets in patients with BPH.

Start Date13 Jun 2024

Sponsor / Collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd.

[+1]

CTR20232665

/ CompletedPhase 1

一项在中国健康受试者中评价喹诺利辛片剂单次口服给药及多次口服给药的单中心、随机、双盲、安慰剂对照的安全性、耐受性和药代动力学补充临床试验

[Translation] A single-center, randomized, double-blind, placebo-controlled supplementary clinical trial to evaluate the safety, tolerability and pharmacokinetics of single and multiple oral administration of quinolone tablets in healthy Chinese subjects

主要目的：评价喹诺利辛片剂（以下简称喹诺利辛）在中国健康成年受试者中单次口服6 4 mg 及多次口服 4 8 mg 的安全性和耐受性。次要目的：评价喹诺利辛在中国健康成年受试者中单次口服 6 4 mg 及多次口服4 8mg的药代动力学（ PK ）特征，为后续临床试验设计提供依据。

[Translation]

Primary objective: To evaluate the safety and tolerability of quinolone tablets (hereinafter referred to as quinolone) in healthy Chinese adult subjects after a single oral dose of 6.4 mg and multiple oral doses of 4.8 mg. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of quinolone tablets in healthy Chinese adult subjects after a single oral dose of 6.4 mg and multiple oral doses of 4.8 mg, and to provide a basis for the design of subsequent clinical trials.

Start Date29 Aug 2023

Sponsor / Collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd.

[+1]

CTR20223098

/ CompletedPhase 1

一项在中国健康受试者中评价喹诺利辛片剂多次口服给药的单中心、随机、双盲、安慰剂对照、剂量递增的安全性、耐受性和药代动力学临床试验

[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of quinolone tablets in healthy Chinese subjects

主要目的：评价喹诺利辛片剂（以下简称喹诺利辛）在中国健康成年受试者中多次口服给药的安全性和耐受性。次要目的：评价喹诺利辛在中国健康成年受试者中多次口服给药的药代动力学（PK）特征，为后续临床试验设计提供依据。

[Translation]

Primary objective: To evaluate the safety and tolerability of quinolone tablets (hereinafter referred to as quinolone) after multiple oral administration in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of quinolone tablets after multiple oral administration in healthy Chinese adult subjects, and to provide a basis for the design of subsequent clinical trials.

Start Date05 Dec 2022

Sponsor / Collaborator

Shanghai Institute of Materia Medica Chinese Academy of Sci

[+1]

100 Clinical Results associated with Quinolicin

Login to view more data

100 Translational Medicine associated with Quinolicin

Login to view more data

100 Patents (Medical) associated with Quinolicin

Login to view more data

100 Deals associated with Quinolicin

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Hyperplasia	Phase 2	China	Jiangsu Kanion Pharmaceutical Co., Ltd.	13 Jun 2024
Prostatic Hyperplasia	Phase 2	China	Shanghai Institute of Materia Medica Chinese Academy of Sci	13 Jun 2024