5-HT1A receptor antagonists(Serotonin 1a (5-HT1a) receptor antagonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor modulators(Dopamine D2 receptor modulators)

+ [2]

Therapeutic Areas

Other Diseases

Active Indication

Schizophrenia

Inactive Indication-

Originator Organization

Zhejiang Jingxin Pharmaceutical Co., Ltd.

Active Organization

Zhejiang Jingxin Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Clinical Trials associated with JX11502MA

CTR20233105 / RecruitingPhase 2

评价JX11502MA片治疗成人急性期精神分裂症有效性和安全性的多中心、随机、双盲、双模拟、阳性对照的Ⅱb期临床试验

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled phase IIb clinical trial to evaluate the efficacy and safety of JX11502MA tablets in the treatment of acute schizophrenia in adults

主要目的：评估JX11502MA片在成人急性期精神分裂症患者中的有效性。次要目的：评估JX11502MA片在成人急性期精神分裂症患者中的安全性。评估JX11502MA片在成人急性期精神分裂症患者的安全和有效的治疗剂量。评估JX11502MA片在成人急性期精神分裂症患者的PK-PD特征。

[Translation]

Primary objective: To evaluate the efficacy of JX11502MA tablets in adult patients with acute schizophrenia. Secondary objective: To evaluate the safety of JX11502MA tablets in adult patients with acute schizophrenia. To evaluate the safe and effective therapeutic dose of JX11502MA tablets in adult patients with acute schizophrenia. To evaluate the PK-PD characteristics of JX11502MA tablets in adult patients with acute schizophrenia.

Start Date27 Nov 2023

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

CTR20213357 / CompletedPhase 1/2

评价JX11502MA胶囊多次给药在精神分裂症患者的安全性、耐受性和药代动力学特征的多中心、随机、双盲、安慰剂对照、剂量递增的Ib/II期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-escalating Phase Ib/II clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of multiple doses of JX11502MA capsules in patients with schizophrenia

主要目的：评估JX11502MA胶囊在精神分裂症患者中多次给药的耐受性和安全性。次要目的：评估JX11502MA胶囊在精神分裂症患者中多次给药的药代动力学特征；探索JX11502MA胶囊对精神分裂症患者的疗效。

[Translation]

Primary objective: To evaluate the tolerability and safety of multiple administrations of JX11502MA capsules in patients with schizophrenia. Secondary objective: To evaluate the pharmacokinetic characteristics of multiple administrations of JX11502MA capsules in patients with schizophrenia; to explore the efficacy of JX11502MA capsules in patients with schizophrenia.

Start Date03 Mar 2022

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

NCT06356389 / CompletedPhase 1/2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of JX11502MA Capsules in Patients With Schizophrenia.

A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia

Start Date02 Mar 2022

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with JX11502MA

100 Translational Medicine associated with JX11502MA

100 Patents (Medical) associated with JX11502MA

Literatures (Medical) associated with JX11502MA

02 Jan 2024·Expert Opinion on Investigational Drugs

Safety, tolerability, and pharmacokinetics of JX11502MA in Chinese healthy subjects: a first-in-human, randomized, double-blind, placebo-controlled study following single-dose administration

Article

Author: He, Jingjing ; Huang, Zhiwei ; Li, Yan ; Shen, Yifeng ; Yu, Yimin ; Wu, Ying ; Zhou, Yanling ; Jin, Zhiping ; Bao, Cungang ; Li, Huafang

BACKGROUNDJX11502MA is a potent partial agonist of dopamine D2 and D3 receptors, with a preferential binding profile for D3 receptors in vitro, potentially for treating schizophrenia.METHODSA first-in-human, randomized, double-blind, placebo-controlled, single ascending dose clinical trial was designed. The subjects were randomly assigned to receive JX11502MA and placebo capsules with seven ascending dose groups: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 6 mg, and 8 mg. The PK profiles of JX11502MA and its metabolites were evaluated, along with a safety and tolerability assessment.RESULTSConsidering the safety of participants, the dose escalation was halted at 3 mg. Following single-dose administration, JX11502MA exhibited rapid absorption with a median T_max ranging from 1 to 1.75 h. The terminal half-life of JX11502MA ranged from 73.62 to 276.85 h. The most common treatment-emergent adverse events (TEAEs) for subjects receiving JX11502MA were somnolence (56.3%), dizziness (18.8%), nausea (21.9%), vomiting (18.8%), and hiccups (18.8%).CONCLUSIONSJX11502MA was generally well tolerated at a single dose of 0.25 to 3 mg. The PK profiles and safety characteristics in this study indicated that JX11502MA has the potential to be a favorable treatment option for patients with schizophrenia.TRIAL REGISTRATIONhttps://clinicaltrials.gov (identifier: NCT05233657).

100 Deals associated with JX11502MA

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Schizophrenia	Phase 2	CN	Zhejiang Jingxin Pharmaceutical Co., Ltd.	27 Nov 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05233657 (Pubmed \| Expert Opin Investig Drugs) Manual	Phase 1	Schizophrenia	-	JX11502MA	(ylphntayiv) = The most common treatment-emergent adverse events (TEAEs) for subjects receiving JX11502MA were somnolence (56.3%), dizziness (18.8%), nausea (21.9%), vomiting (18.8%), and hiccups (18.8%) fhkpuoafcw (muhxapqntp )	Positive	02 Jan 2024

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