[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurodawn Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,70,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637642","phase-1-pharmacokinetics-of-y-4-tablets-with-pregabalin-capsules-and-riluzole-tablets-in-us-healthy-participants-100637642",false,"NCT07618715","Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants","An Open-label, Single-dose, Three-period Phase Ⅰ Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants","Inclusion Criteria:\n\n1. Healthy adult male and female participants, 18-45 years of age (including both ends).\n2. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg\u002Fm2 (including both ends).\n3. During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL\u002Fmin (for female participant, according to the calculation result × 0.85）\n4. Participants who are able to understand and give their signed informed consent before any trial related procedures are performed.\n\nExclusion Criteria:\n\n1. Participants who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry amb Ⅱ), have allergic diseases or allergic constitution;\n2. Participants who have special requirements for diet and cannot follow the unified diet;\n3. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), laboratory tests (Hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;\n4. Participants who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));\n5. History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;\n6. QTcF \\> 450 msec at the screening stage (Corrected using Fridericia's formula: QTcF = QT \u002F(RR\\^0.33), where RR = 60 \u002F heart rate);\n7. Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the participant is not suitable to participate in this trial;\n8. Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines, participants who have impaired hepatic function at the time of screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 1.5 ULN; or total bilirubin (TBIL) \\> 1.0 ULN;\n9. Participants who drink too much tea, coffee and\u002For caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or disagree that any caffeine-containing beverages are prohibited during the trial;\n10. Participants who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;\n11. Participants have disease history or current disease that may affect the safety evaluation of the participant or the internal process of the study drug, including the central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, hematological system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc. In particular, there is a history of dysphagia or any gastrointestinal disease affecting drug absorption (including frequent nausea or vomiting caused by any cause) and eye diseases;\n12. Donation or loss of blood equal to or in excess of 400 mL, or blood transfusion within 3 months prior to screening; or donation or loss of blood equal to or in excess of 200 mL within 1 month prior to screening;\n13. Participants who have taken any drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes within 2 months prior to screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or participants who have taken any prescription drugs, over-the-counter drugs and traditional Chinese medicine or herbal medicine other than the above drugs within 14 days prior to screening;\n14. Participants who have taken central nervous system (CNS) depressants including opioids (pethidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl, Tramadol, etc), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam, chlordiazepine and triazolam etc), antiepileptic drugs (carbamazepine, sodium valproate, phenobarbital drugs etc) within 2 months prior to screening;\n15. Participant with sleep apnea, or participants with severe sleep snoring and daytime drowsiness;\n16. Participants with history of neuropsychiatric disorders, including current or past history of mental illness, suicidal ideation based on the C-SSRS score of 1 or higher;\n17. Participant participated in any other clinical trials within 3 months prior to screening;\n18. Current or former drug users, or positive urine screen for drugs of abuse at screening (screening items include: Opiates, Amphetamines, Cocaine, Cannabinoids, Barbiturates, Benzodiazepines);\n19. Alcoholics or regular drinkers within 3 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath test results are greater than 0.0 mg\u002F100 mL, or who cannot abstain from alcohol during the trial;\n20. Smokers or those who cannot comply with the prohibition of smoking during the trial, or positive for cotinine screening;\n21. Participants who is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody;\n22. Male participants (or their partners) or female participants have baby plans during the whole trial period and within 3 months after the end of the trail, or participants are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the trial period.\n23. Female participants who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women;\n24. Participants with poor compliance or other factors unsuitable for participation in this trial.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},11,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition.\n\nThe secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.",[28],"Healthy Male and Female Subjects",[30,31,32],"Phase Ⅰ","Y-4 Tablet","Postherpetic Neuralgia","NOT_YET_RECRUITING","2026-05-24",{"date":36,"type":37},"2026-06-01","ACTUAL",{"date":39,"type":22},"2026-06-30",{"date":41,"type":22},"2026-10-31",{"name":43,"class":44},"Neurodawn Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100614143","phase-2-y-4-to-treat-the-postherpetic-neuralgia-100614143","NCT07275762","Y-4 to Treat the Postherpetic Neuralgia","A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Y-4 Tablets in Chinese Patients With Postherpetic Neuralgia, Compared With Pregabalin Capsules","Inclusion Criteria:\n\n\\- 1. Able to understand and voluntarily sign the informed consent form. 2. Age ≥ 18 years, any gender. 3. Diagnosed with PHN, meaning pain persists for more than one month after the acute shingles rash has healed.\n\n4\\. VAS score in SF-MPQ ≥ 40 mm of the last 24 hours during screening.\n\nExclusion Criteria:\n\n* 1\\. Known previous allergy to the investigational products, rescue medication ingredients, other chemically similar drugs, or excipients.\n\n  2\\. During screening, individuals who have been clearly diagnosed with peripheral neuropathy or pain unrelated to PHN (including but not limited to those caused by cerebrovascular disease, Guillain-Barré syndrome, cervical or lumbar spine disorders, osteoarticular or tendon lesions, chronic kidney disease or uremia, thyroid disease, intracranial tumors, trauma, etc.) and are judged by the investigator to potentially confound the assessment of PHN.\n\n  3\\. During screen, suffer from a systemic disease that, in the opinion of the investigator, may affect the patient's participation in the study or affect the evaluation of the efficacy of PHN, including but not limited to:\n  1. Severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia within 6 months prior to screening, NYHA cardiac function classification of grade III\\~IV at screening, hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg at screening), recurrent asthma attacks, etc.;\n  2. Chronic digestive diseases, such as liver fibrosis, chronic active hepatitis, peptic ulcer, etc.;\n  3. Neuropsychiatric disorders, including epilepsy, recurrent dizziness or headache, cognitive impairment; Cerebrovascular disease (such as cerebral infarction) or recurrent transient ischemic attack within 6 months prior to screening;\n  4. History of malignant tumors within 5 years prior to screening (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary thyroid carcinoma);\n  5. Presence of active infection, which, in the opinion of the investigator, is not suitable for entry into this study;\n  6. Diabetic patients with poor glycemic control (peritoneal venous blood glucose ≥11mmol\u002FL at screening);\n  7. Suffering from immunocompromised diseases, such as systemic lupus erythematosus, acquired immunodeficiency syndrome, immunosuppressant therapy for autoimmune diseases.\n\n  4\\. During screening, situations may exist that investigators believe could affect pain assessment, such as if the affected skin area has a skin condition that may influence sensation.\n\n  5\\. Previously received nerve destruction for PHN, or underwent minimally invasive interventions (such as nerve blocks or neurostimulation), physical therapy (such as red light therapy), or traditional Chinese external treatments (such as acupuncture) within one week prior to screening.\n\n  6\\. Use prohibited drugs within the first 5 half-lives, or change the restricted drug dosage within the first 14 days.\n\n  7\\. Severe hematological, hepatatological, and renal function abnormalities at the time of screening, which meet any of the following laboratory test results: 1) Hematology: neutrophil count \\\u003C 1.5×109\u002FL, or platelet \\\u003C 90×109\u002FL, or hemoglobin \\\u003C100g\u002FL; 2) Liver function: ALT or AST \\> 2.5 times ULN; or TBIL \\> 1.5 times ULN; 3) Renal function: CrCL\\\u003C60 mL\u002Fmin\u002F1.73 m2 (calculated based on Cockroft-Gault formula a); 4) Creatine kinase \\>2-fold ULN.\n\n  8\\. Participants already diagnosed with sleep apnea, or those with severe snoring and daytime sleepiness, as well as intermittent hypoxia.\n\n  9\\. Participants with a history of suicidal behavior, or those assessed to have suicidal tendencies using the Columbia-Suicide Severity Rating Scale (C-SSRS).\n\n  10.Hepatitis B surface antigen (HBsAg) positive and HBV-DNA titer \\>lower limit of reference value, or hepatitis C virus antibody (HCV-Ab) positive and HCV-DNA titer \\>lower limit of reference value, or human immunodeficiency virus antibody (HIV-Ab) positive, or serum Treponema pallidum-specific antibodies (TP-Ab) positiv eand rapid plasma reagin\u002Ftoluidine red unheated serum test (RPR or TRUST) positive at screening.\n\n  11\\. Known drug abuse, or history of alcohol abuse within 1 year prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine).\n\n  12\\. Pregnant or lactating females. 13.Male (or their partner) or female subjects have a fertility plan during the whole study period and within 1 month after the end of the study or are unwilling to take one or more non-drug contraceptive measures (such as condoms, intrauterine devices, etc.) during the study period.\n\n  14.Prior participation in any other clinical study of any other drug within 30 days prior to screening.\n\n  15.Engaging in high-altitude work, driving motor vehicles, or operating heavy machinery with associated risks during the study period.\n\n  16.Other conditions that are considered unsuitable by the investigator to participate in this clinical study.",{"count":54,"type":22},160,[56],"PHASE2","The goal of this clinical trial is to assess the efficacy and safety of Y-4 in patients with postherpetic neuralgia(PHN).\n\nThe main questions it aims to answer are: The efficacy and safety of Y-4 to treat PHN compared with pregabalin.\n\nResearchers will analyze data from different groups, includes Y-4 group and pregabalin group , to see efficacy of Y-4 and If drug Y-4 is safe and tolerate in the patients with PHN.\n\nParticipants will :\n\n* Take Y-4 (1w titration period: 75 mg pregabalin +18.75 mg riluzole, 12w fixed dose period: 150 mg pregabalin +37.5 mg riluzole, 1w drug withdraw period: 1w titration period: 75 mg pregabalin +18.75 mg riluzole) or pregabalin(75 mg for 1w titration period , 150 mg for 12w fixed dose period ,75 mg for 1w drug withdraw period) twice a day for 14 weeks after run-in period (placebo) lasting for 1 week.\n* Visit the hospital according to the follow-up schedule agreed upon with your doctor. contact the research staff as soon as possible to reschedule when unable to attend the scheduled study visit.\n* Use investigational products as directed by the doctor and undergo the related treatment.\n* Inform their investigators of any changes in their health, including any side effects or symptoms, whether or not they believe these changes are related to the trial medication, as well as any new medications they are using or wish to use, or any changes in the dosage of medications they have already taking.\n* Use reliable contraceptive methods , such as abstinence, intrauterine devices, double barrier methods (e.g., condom with spermicide or condom with a diaphragm containing spermicide), contraceptive implants, or oral contraceptives (except if the partner is infertile) during the study period and within one month after the study is completed.\n* Must inform investigators immediately if they or their partner become pregnant during the study.\n* Be sure to inform other doctors being consultant that you are participating in this clinical study.\n* Restrict medication use and treatment during the study.",[32,59,60],"Y-4","Pregabalin","RECRUITING","2026-05-09",{"date":64,"type":37},"2026-05-13",{"date":66,"type":37},"2026-02-02",{"date":68,"type":22},"2026-11-30",{"name":43,"class":44},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":45},"100605735","phase-1-rk-4-intracalvariosseous-injection-in-treatment-of-acute-large-hemispheric-infarction-100605735","NCT07166380","RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction","An Open-label, Blinded Ib\u002FIIa Study Investigating the Treatment of Acute Large Hemispheric Infarction by Transcranial Bone Marrow Injection of RK-4 Injection","Inclusion Criteria:\n\n1. 18≤ age \\\u003C 81 years old, gender is not limited;\n2. The modified Rankin score (mRS) score ≤ 1 point before the onset of stroke;\n3. Administration can be completed within 24 hours after the onset of symptoms and signs of neurological deficit (for subjects with stroke after waking up or stroke without witnesses, the last normal time of symptom onset is the time of symptom onset);\n4. Clinical symptoms, signs and imaging diagnosed as cerebral infarction in the middle cerebral artery blood supply area, and the following characteristics are met:\n\n   1. 16≤NIHSS score ≤32 points, sum of the fifth upper limb and sixth lower limb scores≥6;\n   2. Imaging suggests the core area of infarction: cerebral blood flow (CBF) in electronic computed scan perfusion imaging (CTP) \\\u003C 30% volume or apparent diffusion coefficient (ADC) value in magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequence \\\u003C 70-300ml of 620×10-6mm2\u002Fs lesion volume or ASPECTS score of 0-6 points. Priority is given to CTP test results. If both CTP and DWI are completed during the screening period and the examination results are inconsistent, the investigator needs to take all information (scanning time, imaging method for optimal response infarct size, etc.) into account and then make a reasonable judgment and record that; ASPECTS scores can be based on CTP or MRI, but CTP is preferred.\n5. If vascular reperfusion therapy is performed, the treatment is not effective and the following conditions are met:\n\n   1. Extended thrombolytic grading (eTICI) = 2a;\n   2. NIHSS score did not improve or progressed after vascular reperfusion treatment and the total score was still ≤ 32 points.\n\n   Note: A decrease of 1 point or more is an improvement, and an increase of 1 point or more is progress.\n6. Subjects or their legal representatives voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n\\-\n\nThose who meet one of the following items at screening cannot be enrolled:\n\n1. Concurrent cerebrovascular disease meets one of the following conditions:\n\n   1. Combined with acute cerebral hemorrhage and subarachnoid hemorrhage;\n   2. Combined with acute posterior circulation cerebral infarction, or severe posterior circulation vascular stenosis (\\>70%);\n   3. Imaging suggests bilateral involvement of the cerebral infarction area;\n   4. The cause has been diagnosed by TOAST typing before screening, and other etiologies such as intracranial artery dissection, vasculitis, and moyamoya disease have been identified\n2. Hemorrhage transformation in the infarct area, the hematoma area ≥ 30% of the infarcted area, and has an obvious mass occupancy effect;\n3. Presence of clinical signs of cerebral herniation, e.g., unilateral or bilateral pupil dilation, fixation; Cerebral edema-related loss of consciousness (NIHSS 1a\\>2 points), or other brainstem reflex loss judged by the investigator caused by cerebral edema or cerebral herniation formation; or other unstable signs of vital signs that are difficult to control;\n4. Planned cranial decompression flap decompression at screening;\n5. Refractory hypertension (systolic blood pressure \\>200mmHg or diastolic blood \\>110mmHg) or hypotension (systolic blood pressure \\\u003C70mmHg or diastolic blood pressure \\\u003C50mmHg) that is difficult to control with medication;\n6. Abnormal blood glucose (random venous blood glucose \\\u003C 2.8mmol\u002FL or \\>23mmol\u002FL);\n7. Obvious abnormal liver function indicators or obvious abnormal renal function indicators; Note: Obvious abnormalities in liver function indicators refer to serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN); Significant abnormal renal function measures are defined as eGFR less than 60 mL\u002Fmin\u002F1.73 m² (eGFR is calculated using the CKD-EPI formula).\n8. Acute ST-segment elevation myocardial infarction (MI), and\u002For acute decompensated heart failure (according to New York College of Cardiology (NYHA) cardiac function class III and IV) within the past 3 months\\];\n9. Contraindications to transcranial bone marrow administration, such as skull fracture, skull infection, subdural\u002Fexternal hematoma, subscalp hematoma, scalp skin or subcutaneous infection, cranial plate obstruction in the past 3 months, etc.;\n10. Bleeding tendency that is not conducive to operation in the opinion of the investigator, including but not limited to: platelet count \\\u003C100×109\u002FL, presence of coagulation dysfunction diseases such as hemophilia, etc.;\n11. Presence of severe or very severe anemia (hemoglobin \\\u003C 60 g\u002FL);\n12. Combined with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) that need to be corrected by endotracheal intubation, tracheostomy or ventilator;\n13. Subjects have severe local or systemic infections within 3 days before screening, including but not limited to severe local symptoms due to infection, such as suppuration, severe pain, tissue necrosis, or clear systemic infection-related symptoms, such as rapid onset of high fever (\\>38.5°C), rapid heart rate, chills, impaired consciousness, dyspnea, shock, etc. caused by infection;\n14. Diagnosed serious CNS degenerative diseases, such as Alzheimer's disease (AD), Parkinson's disease (PD) and severe dementia caused by various reasons or mental system diseases (such as schizophrenia, depression, etc.);\n15. Previously diagnosed with severe systemic disease, with an expected survival of \\\u003C 90 days;\n16. Known allergy to any component of the treatment drug and contrast agent during the study process;\n17. Subjects who are pregnant, lactating, or have possible pregnancy and plan to become pregnant;\n18. Subjects are unable to comply with the study protocol or follow-up requirements;\n19. Those who have participated in any other interventional clinical trial within 3 months before screening, or are currently participating in any other clinical trial;\n20. The investigator believes that he is not suitable to participate in this clinical study.\n\nAfter enrollment, if the subject is found to have violated the enrollment criteria or met the exclusion criteria; such as the age is found to be greater than or equal to 81 years old or malignant tumors or other aspects that do not meet the inclusion criteria, the investigator can judge whether it is suitable to continue to participate in the study based on the risks and benefits.","80 Years",{"count":79,"type":22},18,[25,56],"An open-label, blinded Ib\u002FIIa study investigating the treatment of acute large hemispheric infarction by transcranial bone marrow injection of RK-4 injection\n\nFor subjects with acute large hemispheric infarction who are contraindicated to vascular recanalization or have poor response to vascular recanalization therapy, the safety, tolerability, and PK characteristics of RK-4 injection injected into the brain cell marrow through the cranial bone marrow will be preliminarily evaluated, and the efficacy will be preliminarily explored. The main questions it aims to answer are:\n\n* If drug RK-4 is safe and tolerate in the patients with LHI?\n* What the pharmacokinetic profiles of RK-4 injection injected into the brain cell marrow through the cranial bone marrow?\n* The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow Researchers will analyze data from different groups, includes low dose group (1mg，QD), medium dose group(2mg，QD), high dose group(4mg，QD), to see If drug RK-4 is safe and tolerate in the patients with LHI and the pharmacokinetic profiles and efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow.\n\nParticipants will:\n\n* Take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days.\n* Truthfully provide medical history and \"previous participation in clinical trials\" and a statement of no history of mental disorders.\n* Take the drug at the specified time every day according to the dosage prescribed by the doctor\n* Receive the investigational drug as instructed by the doctor and visiting as required\n* Tell the investigators about any medications (including chemicals, biological drugs, proprietary Chinese medicines, etc.) and related treatments you take during the study\n* unpermitted stop the investigational drug yourself at the end of the study or when you decide to withdraw from the study, you need to stop the investigational drug as directed by your doctor to ensure your safety\n* take reasonable contraception actions\n* unallowed to use unmarketed drugs or other clinical trial drugs during the study",[83,84,85,86],"Transcranial Bone Marrow Injection","RK-4","Acute Large Hemispheric Infarction","Acute Ischemic Stroke","2025-09-24",{"date":89,"type":37},"2025-09-30",{"date":91,"type":22},"2025-09-20",{"date":93,"type":22},"2026-05-19",{"name":43,"class":44},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100597201","phase-1-y-3-for-injection-in-patients-with-hepatic-insufficiency-and-healthy-subjects-100597201","NCT07055412","Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects","To Evaluate the Pharmacokinetics and Safety of Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria for inclusion:\n\n  1. The subject fully understands the purpose and requirements of this trial, voluntarily participates in the clinical trial and signs a written ICF, strictly abide by the clinical study protocols and requirements to complete the whole study process;\n  2. Be 18\\~70 years old (including the boundary value) on the day of signing the ICF, both male and female;\n  3. At screening, the weight of male subjects ≥ 50kg, the weight of female subjects ≥ 45kg, and the body mass index \\[BMI=Weight (kg)\u002Fheight 2 (m2)\\] within the range of 18.0\\~30.0kg\u002Fm2 (including boundary value);\n  4. Subjects (including their spouses or partners) have no sperm or egg donation programs, no fertility plans, and voluntary strict contraceptive use during the trial and within 3 months after the completion of the trial, see Appendix 1: Contraceptive measures administration and contraceptive requirements;\n  5. The estimated glomerular filtration rate (eGFR) calculated using the modification of diet in renal disease (MDRD) formula ≥ 80 ml\u002Fmin\u002F1.73 m2. (See Appendix 2: Glomerular Filtration Rate Calculation Formula);\n\n     Subjects with hepatic insufficiency must also meet all of the following criteria:\n  6. Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, non-alcoholic liver disease, fatty liver, etc.) or clinical diagnosis of liver cirrhosis (see Appendix 3: Diagnostic Criteria for Liver Cirrhosis) caused by primary liver disease, Child-Pugh grade A or B patients with hepatic insufficiency (see Appendix 4: Liver Function Assessment for Child-Pugh classification), and have not used albumin within 14 days before screening, and the investigator judged that patients with mild hepatic insufficiency need to be clinically stable ≥for 28 days before taking the investigational products, and patients with moderate hepatic insufficiency need to be clinically ≥stable for 14 days before taking the investigational products, and the investigator judges that the subject's liver function status is stable from 2 weeks before screening to the end of the study, and no obvious deterioration will occur;\n  7. Have not taken any medication within 1 week before screening; or those who require long-term treatment for liver damage, complications and\u002For other concomitant diseases should have stable medication for at least 4 weeks (stable medication is judged by the investigator, except for drugs prohibited by the protocol).\n\n     Subjects with normal liver function also need to meet all of the following criteria:\n  8. The demographic mean of subjects in the normal hepatic function group (Group C) at screening must meet the following matching standard:\n\n     1. Sex matching with liver insufficiency group (group A and group B), with a mean value of ±1 case;\n     2. Age matching with hepatic insufficiency group (Group A and Group B) with a mean ± 10 years;\n     3. Body weight matching with hepatic insufficiency group (group A and group B) with a mean of ±10%.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be eligible for inclusion in this study:\n\n  1. Irritable the physique, such as those with a known history of allergy to two or more substances, or those with allergic diseases, or those with a history of allergy to investigational products or excipients (15-hydroxystearate polyethylene glycol, propylene glycol, potassium dibasic phosphate, potassium dibasic phosphate trihydrate, mannitol);\n  2. Those who have special dietary requirements and cannot comply with the uniform diet;\n  3. Patients with clinically significant ECG abnormalities (tachycardia\u002Fbradycardia, II-III degree atrioventricular block or QTcF interval prolongation (QTcF\\>450ms for males and \\>470ms for females) (corrected according to Fridericia's formula: QTcF=QT\u002F(RR\\^0.33), RR=60\u002Fheart rate) or other clinically significant abnormalities judged by the investigator to be unsuitable for participating in this study);\n  4. Those who have serious infection, trauma, gastrointestinal surgery or other surgical procedures within 4 weeks before screening, or those who plan to undergo surgical treatment during the trial or have a tendency to be hospitalized;\n  5. Those who have lost blood or donated ≥ 400 mL of blood within 3 months before dosing, or who have received blood transfusion or used blood products within 1 month, or who plan to donate blood within 1 month after the end of this trial;\n  6. Those who have used medium or strong inhibitors or inducers of CYP450 enzyme within 1 month before dosing (such as phenytoin, rifampicin, carbamazepine, fluvoxamine, enoxacin, ticlopidine, gemfibrozil, clopidogrel, clarithromycin, itraconazole, ketoconazole, ritonavir, etc., see Appendix 5: List of Common Drugs for CYP Enzyme Inhibitors or Inducers) or UGT enzyme inhibitors or inducers (such as atazanavir, probenecid, valpendict, mefenamic acid, carbamazepine, rifampicin) within 1 month before dosing , phenytoin, efaviren, phenobarbital, ritonavir, etc., see Appendix 6: List of common drugs for UGT enzyme inhibitors or inducers);\n  7. Those who have consumed excessive amounts of tea, coffee and\u002For caffeinated beverages per day (an average of more than 8 cups per day, 1 cup = 250mL) within 3 months before screening, and those who cannot withdraw during the trial; or those who have consumed a special diet (including dragon fruit, mango, grapefruit, xanthine-rich food, chocolate, etc.) within 2 weeks before screening;\n  8. Those who have participated in other clinical trials and received investigational products within 3 months before screening, or those who plan to participate in other clinical trials during this study;\n  9. Those who are current or previous alcoholics or regular drinkers within 6 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine), or those who have a positive alcohol breath test at baseline (alcohol breath test result \\>0 mg\u002F100 mL) or those who cannot withdraw during the trial;\n  10. Those with a history of drug abuse or drug use or a positive urine drug screen;\n  11. Those who are cigarette-addict or smoking more than 5 cigarettes per day within 3 months prior to screening or habitual use of nicotine-containing system and are unable to withdraw during the test;\n  12. Those who have received vaccination within 30 days before screening, or plan to be vaccinated during the study;\n  13. Pregnant or lactating women, or women of childbearing age who have a positive blood pregnancy test;\n  14. Patients who have difficulty in venous blood collection and cannot tolerate venipuncture or fainting needles and blood;\n  15. Subjects with poor compliance in the opinion of the investigators, or with other factors that are not suitable for participating in this trial.\n\n      Subjects with hepatic insufficiency who meet any of the following exclusion criteria are excluded:\n  16. Subject has any of the following conditions: drug-induced liver injury, history of liver transplantation, acute liver impairment due to various causes, liver failure complicated by infection and\u002For hepatic encephalopathy, hepatocellular carcinoma;\n  17. Patients with liver cirrhosis who are considered inappropriate by the investigator, such as hepatorenal syndrome, active bleeding caused by esophageal and gastric variceal rupture, severe\u002Fadvanced ascites or pleural effusion requiring puncture and drainage and albumin supplementation;\n  18. Patients with primary biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that affect bile excretion;\n  19. Laboratory test results consistent with any of the following at screening: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5×ULN; (b) Absolute neutrophil value (NE#) \\\u003C 0.75×109\u002FL; (c) Hemoglobin (HGB) \\\u003C 80 g\u002FL;(d) Abnormal alpha-fetoprotein (AFP) value (\\>100ng\u002FmL) requiring liver ultrasonography or other imaging examinations (CT, MRI, etc.), excluding subjects with suspected hepatocellular carcinoma; (e) Platelet \\\u003C 50×109\u002FL;\n  20. Those who are screened positive for HIV antibody and Treponema pallidum specific antibody;\n  21. In addition to the primary liver disease itself, those who have suffered from other serious organ system diseases in the past or at present, including but not limited to gastrointestinal, respiratory, renal, neurological, hematologic, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases, which are judged by the research doctor to be unsuitable for participating in this trial;\n  22. Those who have used any prescription medicines, over-the-counter medicines, any vitamin products or Chinese herbal medicines other thanmedicines for the treatment of liver insufficiency or their comorbid chronic diseases within 14 days before administration;\n  23. Systolic blood pressure \\> 160mmHg or diastolic blood pressure \\> 100mmHg; Pulse \\\u003C 50 bpm or \\> 100 bpm;\n\n      Subjects with normal hepatic function who meet any of the following exclusion criteria are excluded:\n  24. Those who have a history of liver impairment in the past, or those who have and may have liver impairment as indicated by physical examination and laboratory examination at screening;\n  25. Those who have suffered or are currently suffering from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, cardiovascular and cerebrovascular, psychiatric and metabolic abnormalities or any other diseases that can interfere with the test results;\n  26. Those with abnormal physical examination, vital signs, laboratory tests (Hematology, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior position), abdominal B-ultrasound (liver, spleen, gallbladder, pancreas, and both kidneys) and other examination abnormalities judged by the investigator to be clinically significant;\n  27. Those who test positive for hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody, and Treponema pallidum specific antibody;\n  28. Have taken any medication (including prescription medicine, over-the-counter medicine, Chinese herbal medicines, vitamins, health products) within 14 days prior to dosing.","70 Years",{"count":104,"type":22},24,[25],"The goal of this clinical trial is to assess the pharmacokinetic profiles and safety of Y-3 in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function, so as to provide a scientific basis for rational clinical medication in patients with hepatic insufficiency.\n\nThe main questions it aims to answer are:\n\nWhat the pharmacokinetic profiles of Y-3 (40 mg ) in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function？ If drug Y-3 (40mg ) is safe and tolerate in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function.\n\nInvestigators will compare pharmacokinetic safety profiles of Y-3 (40 mg ) in subjects with different hepatic functions( mild hepatic insufficiency, moderate hepatic insufficiency, normal.\n\nParticipants will:\n\nTake drug Y-3 (40 mg) only once. Answer questions regarding your medical history. Comply with the study procedures and requests. Complete all tests and collections of PK Sampling. Fasting for more than 10 hours before administration, water abstinence for 1 h before and after administration, and eating standard lunch and dinner 4 hours and 10 hours after starting administration.\n\nMust not use of nicotine-containing products (including nicotine patches). Must not do strenuous exercise for 1 hour before each clinical laboratory test blood draw. Subjects may engage in light recreational activities for the duration of the study.\n\nFollow your doctor's instructions, answer the investigator's questions about your health status truthfully, and cooperate with the test-related tests.\n\nDuring the experiment, the test should be completed in strict accordance with the requirements of the investigator, and the test-related work such as drug administration and sample collection should be conscientiously cooperated, and the research center should not leave the research center without authorization, and the rules and regulations of the research center and the investigator 's propaganda and education should be observed. Any medication taken should be reported truthfully.\n\nMust come to the hospital at the agreed follow-up time with the investigator and you.\n\nInform the investigator or relevant person about any changes in your health status, including any favorable or unfavorable changes.\n\nMust not participate in any other drug clinical trials during this trial. Must tell your investigator about all medical treatments you plan to receive during the study, such as elective surgery or radiation therapy.\n\nIn addition to yourself, at least one member of your family is expected to be aware of the clinical research you will be involved in and care about your health, and will be able to provide feedback to your doctor about your health during follow-up visits. Your family should promptly notify your study physician if you become seriously unwell, including hospitalization for treatment.\n\nNotify your investigator if your address, phone number, or other contact information changes.\n\nMust not use medications that may interfere with PK or safety.",[108,109,110,111,112,113],"Pharmacokinetic Differences","Y-3","Saftey","Mild Hepatic Insufficiency","Moderate Hepatic Insufficiency","Normal Hepatic Function","2025-06-29",{"date":116,"type":37},"2025-07-08",{"date":118,"type":22},"2025-07-10",{"date":120,"type":22},"2025-12-31",{"name":43,"class":44},""]