[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Zhimeng Biopharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100611306","phase-2-an-open-label-study-to-evaluate-safety-tolerability-and-efficacy-of-cb03-154-in-subjects-diagnosed-with-epilepsy-100611306",false,"NCT07238868","An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy","A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed With Epilepsy","Inclusion Criteria:\n\n* 1\\. The subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.\n\n  2\\. Subject must have successfully completed the DBP and have not terminated early from Study CB03-154-EP201, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study, and judged to be efficacious based on the blinded data review (in the opinion of the investigator).\n\n  3\\. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.\n\n  4\\. Subject is able to keep accurate seizure diaries.\n\nExclusion Criteria:\n\n\\- 1. Subject met any of the withdrawal criteria while in Study CB03-154-EP201. 2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study CB03-154-EP201) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.\n\n3\\. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy during the study and until 28 days after completion of this study.","ALL","18 Years","70 Years",{"count":20,"type":21},144,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.",[27],"Focal Epilepsy","RECRUITING","2025-11-16",{"date":31,"type":32},"2025-11-20","ACTUAL",{"date":34,"type":32},"2025-08-14",{"date":36,"type":21},"2029-06",{"name":38,"class":39},"Shanghai Zhimeng Biopharma, Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100600312","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-zm-h1505r-in-patients-with-chb-100600312","NCT07095855","A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB","A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months","Inclusion Criteria:\n\n* 1.Able to understand and sign the written informed consent form;\n* 2.Adult males and females aged 18-65 years(inclusive) at screening;\n* 3.Have been used NAs monotherapy with ETV(0.5 mg or 1.0mg, QD),TDF (300 mg, QD),TAF (25 mg, QD),or TMF (25 mg, OD)for at least 12 months at the time of enrollment; Have been on stable and continuous use of one of these medications for at least 6months, and do not plan to switch to any other NAs class of medications after entering this clinical trial;\n* 4.Evidence of prior HBV infection (e.g., HBsAg and\u002For HBV DNA positive), or HBsAg positive at screening;\n* 5.HBV DNA ≥50 IU\u002FmL as measured by a local healthcare facility within 30 days prior to screening and HBV DNA ≥50 IU\u002FmL as confirmed by central laboratory testing at the time of screening;\n* 6.HBeAg positivity confirmed by central laboratory testing at screening;\n* 7.Women of childbearing potential or males with female partners of childbearing potential must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 28 days after the last dose of the study.\n\nExclusion Criteria:\n\n* 1.Progressive fibrosis or cirrhosis detected at screening, or progressive fibrosis or cirrhosis defined as follows: Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by liver biopsy within 1 year prior to screening; or in the absence of an appropriate liver biopsy, liver stiffness test (FibroScan) ≥ 9 kPa within 3 months prior to screening, or liver stiffness test (FibroTouch) ≥ 9.6 kPa(FibroScan preferred) ;\n* 2.History of hepatocellular carcinoma (HCC); or serum alpha-fetoprotein (AFP) ≥ 50 ng\u002FmL at screening, or imaging examination such as abdominal ultrasound, CT (computed tomography) or MRI (magnetic resonance imaging) suggesting possible HCC;\n* 3.Subjects meeting any of the following clinical laboratory parameters at screening:\n\n  1. Hemoglobin \\\u003C 110 g\u002FL (for males) or \\\u003C 100 g\u002FL (for females);\n  2. Platelet count \\\u003C 90 × 109\u002FL;\n  3. Neutrophil count \\\u003C 1.5 × 109\u002FL;\n  4. Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)\\> 3 × upper limit of normal (×ULN);\n  5. International normalized ratio (INR) of prothrombin time \\> 1.3;\n  6. Albumin \\\u003C 35 g\u002FL;\n  7. Total bilirubin \\> 2 × ULN, and direct bilirubin \\> 1.5 × ULN;\n  8. Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2(calculated using the CKD-MDRD formula).\n* 4.Abnormal result of electrocardiogram (ECG) at screening and inappropriate for the study participation judged by the investigator; or QTcF (QT corrected using the Fridericia formula): \\> 450 ms for males, \\> 470 ms for females at screening;\n* 5.Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV); Note: Subjects with positive HCV antibody (Ab) but negative HCV RNA and subjects with positive HEV immunoglobulin M (IgM) but negative HEV RNA will NOT be excluded.\n* 6.Other malignancy unless the subject's malignancy has been cured by surgical resection (e.g., basal cell skin cancer); Note: Subjects who are suspected of having malignancy must be excluded regardless of evidence of local recurrence or metastasis.\n* 7.History of chronic liver disease with a non-HBV etiology, such as alcoholic liver disease, autoimmune liver disease, hereditary liver disease, non-alcoholic fatty liver disease, except for simple fatty liver disease;\n* 8.Other concurrent severe systemic diseases or clinical manifestations, for which the investigator considers not suitable to participate in this study;\n* 9.Use of any investigational product or drug not approved by regulatory authorities within 3 months prior to screening;\n* 10.History of persistent alcohol consumption (alcohol consumption exceeding 40 g ethanol for males or 20g ethanol for females per day on average) within 6 months prior to screening;\n* 11.History of drug dependence or drug abuse;\n* 12.Pregnant or breastfeeding women;\n* 13.Known hypersensitivity to the active ingredient or formulation excipients of the investigational drug;\n* 14.Inappropriate for the study participation for any reason not otherwise listed as judged by the investigator.","65 Years",{"count":50,"type":21},1300,[52],"PHASE3","This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU\u002FmL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.",[55],"Chronic Hepatitis B",[57,58,59],"ZM-H1505R","Hepatitis B","CHB","NOT_YET_RECRUITING","2025-07-30",{"date":63,"type":32},"2025-08-03",{"date":65,"type":21},"2025-08",{"date":67,"type":21},"2030-01",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100599261","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-different-doses-of-cb03-154-in-adult-patients-with-amyotrophic-lateral-sclerosis-als-100599261","NCT07082192","A Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Adaptive Clinical Study and Open-label Extension Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. Agree to follow the treatment plan and trial procedures of this study, and sign the written informed consent form.\n2. Male or female, aged 18 to 65 years, inclusive.\n3. The weight of subjects during the screening period must not be less than 45 kg, and the BMI must not be less than 18 kg\u002Fm2.\n4. Diagnosed according to the Revised EI Escorial diagnostic criteria set by the World Federation of Neurology: definite ALS, probable ALS, lab supported probable ALS, or possible ALS.\n5. Less than or equal to 24 months since ALS symptom onset at Screening, and estimated survival time of ≥1 year as per the Investigator's judgement.\n6. Forced vital capacity (FVC) \\>80% of predicted value for gender, height, and age at Screening.\n7. Able to swallow oral medication (tablets) at Screening as judged by the investigator.\n8. For participants taking riluzole: Dose must be stable for at least 4 weeks prior to Screening and participant must be expected to remain on treatment for the duration of the trial. Participants receiving riluzole should maintain the same dose throughout the study.\n9. Currently not receiving edaravone treatment or is in the schedule of edaravone treatment cycle. Participants receiving edaravone treatment must complete at least one cycle of treatment before the screening visit and continue stable dose edaravone treatment throughout the study.\n10. Women of childbearing potential (WOCBP) must use an approved highly effective contraception for at least one menstrual cycle before the first dose of the investigational product and for at least 3 months after the last dose of the investigational product. Similarly, men must start using effective contraception before the first dose of the investigational product and continue for at least 3 months after the last dose of the investigational product, with no plans for procreation. Male participants cannot donate sperm for at least 3 months during the trial and after the last dose of the investigational product and female participants cannot donate or freeze eggs during the trial and for at least 3 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Significant cognitive impairment, mental disorders (such as schizophrenia, bipolar disorder), other neurodegenerative diseases (such as Parkinson's disease, Alzheimer's disease, frontotemporal dementia, etc.), substance abuse or other causes leading to neuromuscular weakness (such as myasthenia gravis), or other conditions that may interfere with the participants' participation in clinical study or, in the investigator's judgment, may interfere with outcome assessment or affect the completion of the trial.\n2. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin\\>2.0× upper limit of normal at screening.\n3. Estimated glomerular filtration rate \\\u003C59 mL\u002Fmin\u002F1.73m2 at Screening (using the Cockcroft-Gault formula to calculate eGFR: eGFR (mL\u002Fmin\u002F1.73m2) = Ccr × 0.84 × 1.73 \u002F BSA; Ccr (mL\u002Fmin) = \\[(140 - age) × weight (kg)\\] \u002F \\[72 × Scr (mg\u002FdL)\\], females multiply the result by 0.85, and Scr is the serum creatinine; BSA (m2) = 0.007184 × weight (kg)\\^0.425 × height (cm)\\^0.725).\n4. D-dimer\\>2.0× upper limit of normal or venous ultrasound of the lower limbs shows deep vein thrombosis at screening or a history of venous thrombosis.\n5. Assistance with ventilation support or tracheostomy or tube feeding status or having a central venous catheter is required at screening.\n6. A history of unexplained syncope, family history of syncope, or a history of convulsions or epilepsy (excluding the history of febrile seizures in childhood), or unstable medical condition, serious heart issues (e.g., corrected QTcF interval: males \\>450ms, females \\>470ms, torsades de pointes, NYHA class 3 or higher heart failure, myocardial infarction or unstable angina within 6 months prior to screening), lung, liver, kidney diseases, or tumors, or other clinically significant diseases or medical history (excluding ALS), participation in this study could threaten the safety of the participants.\n7. Current clinically significant urinary retention, or current use of medications for urinary retention, or clinically significant abnormalities in residual urinary bladder ultrasound at screening.\n8. Clinically significant ophthalmological abnormalities found in visual acuity examination (best corrected visual acuity), fundus photography, OCT examination, etc. during screening period, or clinically significant fundus lesions or retinopathy known or recorded in medical history.\n9. Hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (HCVAb) positive and hepatitis C virus ribonucleic acid (HCV-RNA) test higher than the lower limit of detection, or human immunodeficiency virus antibody (HIVAb) positive, or Treponema pallidum (TP) antibody positive (also judged as active infection by the investigator) at screening.\n10. Severe infections (e.g., infectious pneumonia, sepsis) within 4 weeks prior to screening, or infections requiring hospitalization or intravenous administration of antibiotics, antiviral drugs, or antifungal medications, or chronic active bacterial infections (e.g., tuberculosis) deemed by the investigator to be unsuitable for participation in this trial.\n11. Received Tofersen treatment before screening.\n12. Significant risk of suicidality based on the Investigator's opinion or with an answer of \"yes\" on either item 4 or item 5 of the Suicidal Ideation Section of the Columbia Suicide Severity Rating Scale (C-SSRS) or any answer of \"yes\" within the Suicidal Behavior Section of the C SSRS within the 6 months before Screening.\n13. Exposure to any other investigational medicinal product or product within 4 weeks or 5 half-lives of the investigational product (whichever is longer) prior to Screening; or exposure to monoclonal antibody drug within 6 months prior to Screening (or if the washout period at the time of screening has not reached more than 3 months), or had received cell therapy or gene therapy at any time in the past.\n14. Treatment with CYP3A4 strong inducers or strong inhibitors prior to screening, and washout time of more than 5 half-lives of the drug was not reached before enrollment。\n15. Pregnant, currently breastfeeding women or women with a positive pregnancy test at screening.\n16. Known history of allergy to any component of the investigational medicinal product.\n17. History of drug abuse within 12 months of Screening.\n18. Anything else that, in the opinion of the Investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the trial.",{"count":77,"type":21},240,[24,52],"The goal of this clinical trial is to learn if drug CB03-154 works to treat ALS in adults. It will also learn about the safety of drug CB03-154.\n\nThe main questions it aims to answer are:\n\n* Does drug CB03-154 have an effect on delaying disease progression, improving function, and prolonging survival in adult ALS patients?\n* What medical problems do patients have when taking drug CB03-154? Researchers will compare drug CB03-154 to a placebo (a look-alike substance that contains no drug) to see if drug CB03-154 works to treat ALS.\n\nParticipants (adult ALS patients) will:\n\n* Take drug CB03-154 or a placebo every day for 39 weeks (an additional 39 weeks would be required if entering the open-label extension phase).\n* Visit the clinic approximately every 2-3 months for checkups and tests, and there is also telephone follow-up in between.\n* Keep a diary of daily medication (CB03-154 or other concomitant medications), and if there are any unplanned medications, the reason (disease or symptoms) also need be recorded.",[81],"ALS (Amyotrophic Lateral Sclerosis)","2025-07-23",{"date":84,"type":32},"2025-07-24",{"date":86,"type":21},"2025-09-29",{"date":88,"type":21},"2027-10",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":25,"conditions":100,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100563177","phase-2-a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-cb03-154-in-adult-patients-with-focal-epilepsy-100563177","NCT06612775","A Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 in Adult Patients With Focal Epilepsy","A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 as Adjunctive Therapy in Focal Epilepsy","Inclusion Criteria:\n\n1. Ability of the subjects or his\u002Fher authorized representative be fully informed of the nature and risks of the study and give informed consent in writing prior to entering the study.\n2. Male and female aged 18 to 70 years, inclusive.\n3. 18.0 kg\u002Fm2 ≤BMI ≤ 34.0 kg\u002Fm2.\n4. Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy \\[ILAE\\] Classification of Epilepsy (2017).\n5. Prior neuroimaging within the last 5 years and documentation are available to rule out progressive structural central nervous system abnormalities at the time of the diagnosis of epilepsy.\n6. Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP.\n7. Prior to screening and during baseline period, subjects must have at least 6 focal seizures without status epilepticus, with or without focal to bilateral tonic-clonic.\n8. If a female, must be:\n\n   * Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed by blood follicle stimulating hormone (FSH) at Screening, OR\n   * Surgically sterile with a documented hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening, OR\n   * If of child-bearing potential, heterosexually active females with male partners must be using an acceptable and highly effective method of contraception at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the last dose of the study drug. If a female subject is abstinent, she must agree to use an acceptable and highly effective form of birth control as above once she becomes heterosexually active during the study.\n9. If a female of child-bearing potential, must have a negative pregnancy test result at Screening and Check-in.\n10. If a male, if heterosexually sexually active with a female partner of child-bearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception and deemed appropriate by the Investigator and must not donate sperm during the study and for 3 months after the last dose of study drug.\n11. Able to keep accurate seizure diaries.\n\nExclusion Criteria:\n\n1. Subject has had documented previous EEGs indicating other patterns of epilepsy besides the focal epilepsy prior to dosing the study drug.\n2. Subject has seizures secondary to drugs or alcohol use, ongoing infection, metabolic diseases or progressive central nervous system diseases or lesions at the investigator's assessments.\n3. Subject has the history of pseudo seizures, conversion disorders, or other non-epileptic seizure conditions, or other non-epileptic ictal events that could be confused with seizures at the investigator's discretion and\u002For EEG evidence.\n4. Subject has the presence or previous history of Lennox-Gastaut syndrome, some other related syndrome or evidence of both focal and generalized epilepsy at investigator's decisions.\n5. Subject has the history of status epilepticus within 6 months prior to screening.\n6. Subject has only uncountably repetitive seizures occurring within 6 months prior to screening.\n7. Subject has the history of neurosurgery for seizures \\\u003C1 year prior to enrolment, or radiosurgery \\\u003C2 years prior to enrolment. Subjects has the implantment and activation of vagus nerve stimulation (VNS), deep brain stimulation (DBS), or other neurostimulation for epilepsy treatment \\\u003C1 year prior to enrolment, or with stimulation parameters that have been stable for \\\u003C3 months prior to enrolment, or with anticipated left battery lifetime shorter than trial duration.\n8. Subject has any of the following findings will be excluded:\n\n   * A history or family history of unexplained syncope;\n   * A history of presence of long QT syndrome; QTcF \\> 450 msec prior to first dose of the study drug; a family history of long QT syndromes or sudden death of unknown cause;\n   * Bundle branch blocks or atrioventricular or other conduction abnormalities that are clinically significant according to the Investigator and\u002For with a PR interval ≥220ms, or HR\\\u003C50bpm at rest in ECGs or vital signs, prior to first dose of the study drug;\n   * A history of venous thrombosis, or a history or presence of medical conditions indicating unresolved high risks of thrombophilia or hypercoagulability including but not limited to protein C deficiency, protein S deficiency, antithrombin deficiency, antiphospholipid syndrome, Budd-Chiari syndrome, myeloproliferative neoplasm including Chronic myeloid leukemia (CML), polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF), autoimmune diseases (especially systemic lupus erythematosus (SLE) or antiphospholipid syndrome or vasculitis), nephrotic syndrome, paroxysmal nocturnal hemoglobinuria, uncured malignancy, unstoppable estrogen containing oral or injection contraception or hormone replacement therapy, postpartum period within 2 months, or other medical conditions at the investigator and the medical monitor's judgements;\n   * Venous ultrasound examinations on bilateral lower extremes indicating DVT;\n   * \\> 2.0 Upper limit of normal (ULN) of blood D-Dimer, or \\>1.5 Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), amylase (AMY) prior to first dose of the study drug. If subject has \\>ULN of above laboratory tests that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase at the investigator's and\u002For the medical monitor's judgments;\n   * The estimated glomerular filtration rate (eGFR) at screening is \\\u003C60mL\u002Fmin and the calculated result of female is ×0.85.\n9. Subject has any clinically significant abnormalities on physical examination, vital signs, laboratory tests or ECG prior to first dose of the study drug which could jeopardize or would compromise the subject's safety or ability to participate in this study as deemed by the Investigator and the Medical monitor.\n10. Subject has the history or presence of significant medical or surgical condition including but not limited to cardiac, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, psychiatric disease, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma, or any condition which could jeopardize or would compromise the subject's safety or ability to participate in this study in the opinion of the investigator and\u002For the medical monitor at enrolment.\n11. Subject with active pathogen infections or carrier including but not limited to testing positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or syphilis.\n12. Subject has schizophrenia and other psychotic disorders, or active suicidal plan\u002Fintent in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening, or a history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) within 2 years prior to enrolment, or more than 1 lifetime suicide attempt.\n13. Subject ever used vigabatrin without no vigabatrin-related visual field abnormalities confirmed by examination within the past 6 months at screening (concomitant use of vigabatrin is not allowed).\n14. If felbamate will be a concomitant AED during study, the subject must be on felbamate for at least 2 years, and with a stable dose for at least 2 months prior to screening and without planned changes of the dose during the study. Subject must not have a history of white blood cell (WBC) count below 3000\u002FμL (3.00 \\*109\u002FL), platelets below 75,000\u002Fmm3 (75\\*109\u002FL), liver function tests above 1.5 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If felbamate was ever used before, it must have been discontinued for at least 2 months prior to screening.\n15. Subject has taken other (non-AED) prescription, nonprescription, dietary (e.g., grapefruit or passion fruit), or herbal products that are potent inducers or strong or moderately inhibitors of the CYP3A4 pathway for 2 weeks prior to the baseline.\n16. Subject has received an investigational medicinal product within 3 months or within 10 half-lives of the drug (whichever is longer) or IMP of monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within 6 months prior to the first dose of study drug.\n17. Subject is known allergic or hypersensitive to any of excipients of CB03-154 tablet formulation.\n18. Subject has had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological, hematological, or organ toxicity reactions.\n19. Subject has a history of indicated alcohol abuse or drug abuse at the investigator's decision during the 6 months prior to screening. Subject tested positive for substance abuse at screening or check-in.\n20. Female subject who is pregnant or in the postpartum period within 2 months or breastfeeding.",{"count":98,"type":21},180,[24],[27],"2024-09-22",{"date":103,"type":32},"2024-09-25",{"date":105,"type":21},"2024-09",{"date":107,"type":21},"2026-09",{"name":38,"class":39},""]