A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are:
* What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers?
* If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Participants will:
* Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once.
* Answer questions regarding your medical history.
* Comply with the study procedures and requests.
* Complete all tests and collections of PK Sampling.
* Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay.
* Must avoid excessive ( > 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study.
* Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study.
* Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study.
* Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study.
* Female participants must not become pregnant while in the study.
* Must not receive any vaccinations during your time in the study.
* Must not donate blood for purposes outside of study procedures during your time in the study.
* Must not drink alcohol during your time in the study.
* Must not smoke during your time in the study.
* Inform your Study Doctor if you no longer wish to participate in the study.

Start Date06 Jan 2025

Sponsor / Collaborator

Neurodawn Pharmaceutical Co., Ltd.

NCT06602115

/ Not yet recruitingNot ApplicableIIT

Noncontrast CT-Based Deep Learning for Predicting Hematoma Expansion Risk in Patients with Spontaneous Intracerebral Hemorrhage

Hematoma expansion is an independent predictor of poor prognosis and early neurological deterioration in patients with spontaneous intracerebral hemorrhage. Early identification of high-risk patients and timely targeted medical interventions may provide a crucial opportunity to limit hematoma growth and improve neurological outcomes. This study aims to develop an end-to-end deep learning model based on noncontrast computed tomography images to predict the risk of hematoma expansion in patients with spontaneous intracerebral hemorrhage. This model could serve as a valuable risk stratification tool for patients with hematoma expansion, facilitating targeted treatment and providing clinicians with streamlined decision-making support in emergency situations.

Start Date25 Sep 2024

Sponsor / Collaborator

Chongqing Medical University /The First Affiliated Hospital/

[+4]

CTR20242311

/ RecruitingPhase 3

注射用Y-3治疗急性缺血性卒中III期临床试验——多中心、随机、双盲、平行、安慰剂对照III期临床研究

[Translation] Phase III clinical trial of Y-3 injection in the treatment of acute ischemic stroke - a multicenter, randomized, double-blind, parallel, placebo-controlled phase III clinical study

评价注射用Y-3治疗发病在48h以内的急性缺血性卒中患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset

Start Date24 Jul 2024

Sponsor / Collaborator

Neurodawn Pharmaceutical Co., Ltd.

100 Clinical Results associated with Neurodawn Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Neurodawn Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Neurodawn Pharmaceutical Co., Ltd.

01 Apr 2024·JAMA Neurology

Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke

Article

Author: Dong, Aiqin ; Li, Shuya ; Liu, Bo ; Sui, Yi ; Sun, Xin ; Shi, Xueying ; Han, Shugen ; Fu, Yu ; Dong, Xueshuang ; Yao, Jinliang ; Tian, Xue ; Yi, Fei ; Ling, Yun ; Feng, Xiaofei ; Tang, Renhong ; Yang, Shibao ; Wei, Yan ; Xia, Xue ; Wen, Guoqiang ; Li, Chuanling ; Fan, Dongsheng ; Deng, Qian ; Guo, Cunju ; Chen, Rong ; Wang, Anxin ; Ren, Jinsheng ; Zhu, Shunwei ; Wang, Zhimin

ImportanceSublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotection composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol.ObjectiveTo investigate the efficacy and safety of sublingual edaravone dexborneol on 90-day functional outcome in patients with acute ischemic stroke (AIS).Design, Setting, and ParticipantsThis was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China. Patients randomly assigned to treatment groups were aged 18 to 80 years and had a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke. Patients who did not meet the eligibility criteria or declined to participate were excluded.InterventionPatients were assigned, in a 1:1 ratio, to receive sublingual edaravone dexborneol (edaravone, 30 mg; dexborneol, 6 mg) or placebo (edaravone, 0 mg; dexborneol, 60 μg) twice daily for 14 days and were followed up until 90 days.Main Outcomes and MeasuresThe primary efficacy outcome was the proportion of patients with mRS score of 1 or less on day 90 after randomization.ResultsOf 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).Conclusion and RelevanceAmong patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.Trial RegistrationClinicalTrials.gov Identifier: NCT04950920

27 Feb 2024·Stroke and vascular neurology

Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial.

Article

Author: Tang, Renhong ; Fu, Yu ; Feng, Xiaofei ; Ren, Jinsheng ; Wang, Anxin ; Chen, Rong ; Zhu, Shunwei ; Fan, Dongsheng

BACKGROUND AND PURPOSEClinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke (AIS). The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with AIS.METHODS AND DESIGNThis is a randomised, double-blind, placebo-controlled, multicentre, parallel-group trial of Y-2 sublingual tablet on patients with AIS.An estimated 914 patients at age of 18-80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 days. Patients are at score 6-20 points on National Institutes of Health Stroke Scale (NIHSS) and had a modified Rankin Scale (mRS) ≤1 before this stroke, except mechanical thrombectomy and neuroprotective agents treatment.STUDY OUTCOMESThe primary outcome is the proportion of patients with mRS ≤1 on day 90 after randomisation. Secondary efficacy outcomes include mRS score on day 90, the proportion of patients with mRS ≤2 on day 90; the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score ≤1 at the days 14, 30 and 90.DISCUSSIONThis trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS.TRIAL REGISTRATION NUMBERNCT04950920.

01 Dec 2023·Stroke and Vascular Neurology

Preclinical evaluation of ZL006-05, a new antistroke drug with fast-onset antidepressant and anxiolytic effects

Article

Author: Wang, Xuan ; Wu, Haiyin ; Chen, Mingyu ; Zhu, Dongya ; Wang, Yilong ; Ren, Jian ; Hua, Yao ; Luo, Chunxia ; Li, Fei ; Song, Yixuan ; Chen, Wei ; Chang, Lei ; Lin, Yuhui ; Shen, Luyao ; Huang, Zhenquan ; Zhou, Ying

BackgroundPoststroke depression and anxiety, independent predictor of poor functional outcomes, are common in the acute phase of stroke. Up to now, there is no fast-onset antidepressive and anxiolytic agents suitable for the management of acute stroke. ZL006-05, a dual-target analgesic we developed, dissociates nitric oxide synthase from postsynaptic density-95 while potentiates α2-containing γ-aminobutyric acid type A receptor. This study aims to determine whether ZL006-05 can be used as an antistroke agent with fast-onset antidepressant and anxiolytic effects.MethodsPhotothrombotic stroke and transient middle cerebral artery occlusion were induced in rats and mice. Infarct size was measured by TTC(2,3,5-Triphenyltetrazolium chloride) staining or Nissl staining. Neurological defects were assessed by four-point scale neurological score or modified Neurological Severity Scores. Grid-walking, cylinder and modified adhesive removal tasks were conducted to assess sensorimotor functions. Spatial learning was assessed using Morris water maze task. Depression and anxiety were induced by unpredictable chronic mild stress. Depressive behaviours were assessed by tail suspension, forced swim and sucrose preference tests. Anxiety behaviours were assessed by novelty-suppressed feeding and elevated plus maze tests. Pharmacokinetics, toxicokinetics and long-term toxicity studies were performed in rats.ResultsAdministration of ZL006-05 in the acute phase of stroke attenuated transient and permanent ischaemic injury and ameliorated long-term functional impairments significantly, with a treatment window of 12 hours after ischemia, and reduced plasminogen activato-induced haemorrhagic transformation. ZL006-05 produced fast-onset antidepressant and anxiolytic effects with onset latency of 1 hour in the normal and CMS mice, had antidepressant and anxiolytic effects in stroke mice. ZL006-05 crossed the blood–brain barrier and distributed into the brain rapidly, and had a high safety profile in toxicokinetics and long-term toxicological studies.ConclusionZL006-05 is a new neuroprotectant with fast-onset antidepressant and anxiolytic effects and has translational properties in terms of efficacy, safety and targeting of clinical issues.

100 Deals associated with Neurodawn Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Neurodawn Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 10 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

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Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Edaravone/(+)-2-Decanol	Acute Ischemic Stroke More	NDA/BLA
Y-3 ( GABAA receptor x PSD95 x nNOS )	Depressive Disorder More	Phase 3
Mecripyrine Hydrochloride ( AChE )	Alzheimer Disease More	Phase 2
Cilostazol/Decanol ( PDE3 )	occlusions More	Phase 2
Pregabalin/Riluzole ( CACNA2D1 x CACNA2D2 x SCNA )	Peripheral neuralgia More	Phase 1

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