[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of levorotatory demethylphencyclonate hydrochloride tablets in patients with early and middle stage Parkinson's disease

主要目的：评价LS001在早、中期帕金森病患者中的安全性、耐受性。次要目的：评价LS001在早、中期帕金森病患者中的药代动力学特征和疗效；探索左旋盐酸去甲基苯环壬酯在帕金森病患者体内的代谢产物。

[Translation]

Primary purpose: To evaluate the safety and tolerability of LS001 in patients with early and middle stage Parkinson's disease. Secondary purpose: To evaluate the pharmacokinetic characteristics and efficacy of LS001 in patients with early and middle stage Parkinson's disease; to explore the metabolites of L-demethylphencyclonate hydrochloride in patients with Parkinson's disease.

Start Date01 Mar 2022

Sponsor / Collaborator

Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA

[+1]

CTR20212522 / RecruitingPhase 2

左旋盐酸去甲基苯环壬酯片（LS001）治疗早、中期帕金森病的随机、双盲、安慰剂对照的剂量探索和耐受性研究

[Translation] A randomized, double-blind, placebo-controlled, dose-finding and tolerability study of LS001 in the treatment of early and mid-stage Parkinson's disease

主要目的：评价LS001在早、中期帕金森病患者中的安全性和耐受性次要目的：评价LS001治疗早、中期帕金森病的初步有效性以及在早、中期帕金森病群体药代动力学特征

[Translation]

Primary objective: To evaluate the safety and tolerability of LS001 in patients with early and middle stage Parkinson's disease Secondary objective: To evaluate the preliminary efficacy of LS001 in the treatment of early and middle stage Parkinson's disease and its pharmacokinetic characteristics in the early and middle stage Parkinson's disease population

Start Date24 Dec 2021

Sponsor / Collaborator

Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA

[+1]

CTR20212501 / CompletedPhase 1

左旋盐酸去甲基苯环壬酯片在健康受试者中的食物影响研究

[Translation] Study on the food effect of L-demethylphencyclonate hydrochloride tablets in healthy subjects

主要目的：观察在中国健康成年受试者中食物对LS001药代动力学特征的影响。次要目的：评价LS001在健康受试者中空腹/餐后服用的安全性；评价LS001在健康受试者中空腹给药后代谢产物的药代动力学特征。

[Translation]

Primary objective: To observe the effect of food on the pharmacokinetic characteristics of LS001 in healthy adult subjects in China. Secondary objective: To evaluate the safety of LS001 in healthy subjects after fasting/postprandial administration; To evaluate the pharmacokinetic characteristics of metabolites of LS001 after fasting administration in healthy subjects.

Start Date19 Oct 2021

Sponsor / Collaborator

Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA

[+1]

100 Clinical Results associated with L-Demethyl Phencynonate Hydrochloride

100 Translational Medicine associated with L-Demethyl Phencynonate Hydrochloride

100 Patents (Medical) associated with L-Demethyl Phencynonate Hydrochloride

100 Deals associated with L-Demethyl Phencynonate Hydrochloride

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	Phase 2	CN	Institute of Poisons and Drugs, Academy of Military Medical Sciences, PLA	24 Dec 2021
Parkinson Disease	Phase 2	CN	Beijing Lansheng Pharmaceutical Technology Co., Ltd.	24 Dec 2021

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