[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PRG Science & Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100609950","phase-1-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-amisodin-in-healthy-adult-subjects-with-amyotrophic-lateral-sclerosis-100609950",false,"NCT07221240","Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects","ALS","Inclusion Criteria:\n\nSubjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:\n\n* 1\\. Healthy, adult, male or female (of non-childbearing potential only)\\*, 18 55 years of age, inclusive, at the screening visit.\n\n  * Females of non-childbearing potential are defined as follows:\n\n    * Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:\n\n      o Hysteroscopic sterilization\n\n      o Bilateral tubal ligation or bilateral salpingectomy\n\n      o Hysterectomy\n      * Bilateral oophorectomy or\n    * Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.\n\n      4\\. Body mass index (BMI) ≥ 18.0 and \\\u003C 32.0 kg\u002Fm2 at the screening visit. 5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:\n    * Seated blood pressure is ≥ 90\u002F50 mmHg and ≤ 140\u002F90 mmHg\n    * Liver function tests at or below limit or normal range\n    * Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation \\[MDRD\\] method) ≥ 90 mL\u002Fmin\u002F1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below:\n    * Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)\n    * QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)\n    * QRS interval \\\u003C 110 msec; if \\> 110 msec, result will be confirmed by a manual over read\n    * PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\nSubjects must not be enrolled in the study if they meet any of the following criteria:\n\n* 1\\. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n\n  2\\. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug, study drug excipients, or antihistamines.\n\n  6\\. Allergy to band aids, adhesive dressing, or medical tape. 7. Female subjects of childbearing potential. 8. Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 9. Positive urine drug or serum alcohol results at the screening visit or first check-in. 10. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 11. Unable to refrain from or anticipates the use of:\n\n  • Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing.\n\n  • Any drugs known to be significant inducers of cytochrome P450s (CYP) and\u002For P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing.\n\n  • Any drugs that prolong the QT\u002FQTc interval within 14 days (or 5 half lives, whichever is longer) prior to the first dosing.\n\n  12\\. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. 13. Donation of blood or significant blood loss within 56 days prior to the first dosing. 14. Plasma donation within 7 days prior to the first dosing 15. Participation in another clinical study within 90 days prior to the first dosing.\n\nThe 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.\n\n16\\. Any other reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study.",true,"ALL","18 Years","55 Years",{"count":22,"type":23},48,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.",[29],"Amyotrophic Lateral Sclerosis","RECRUITING","2026-03-03",{"date":33,"type":34},"2026-03-05","ACTUAL",{"date":36,"type":34},"2025-10-01",{"date":38,"type":23},"2026-07-03",{"name":40,"class":41},"PRG Science & Technology Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100603069","phase-1-study-to-determine-optimal-dose-evaluate-the-efficacy-and-safety-of-prg-n-01-in-patients-with-neurofibromatosis-type-ii-100603069","NCT07131722","Study to Determine Optimal Dose, Evaluate the Efficacy and Safety of PRG-N-01 in Patients With Neurofibromatosis Type II","An Open-Label, Dose-Finding, Phase 1\u002F2a Study to Evaluate the Efficacy and Safety of PRG-N-01 in Patients With Neurofibromatosis Type II","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older at screening\n2. Subjects diagnosed with NF2 clinically or genetically, according to the I-NF-DC 2022 updated NF2 diagnostic criteria\n3. Subjects with tumors due to NF2 who require treatment if they meet one of more of the criteria below but cannot undergo surgical treatment due to high risk of side effects from surgery (e.g., damage to nerve function).\n\n(1) Subjects with progressive tumors (VS, non-VS, meningiomas, ependymomas) confirmed on MRI within 36 months prior to screening (2) Subjects with clinical symptoms (decreased function of affected nerves, such as hearing loss, uncontrolled pain, shortness of breath, difficulty swallowing, decreased motor function, and decreased gait) as judged by the investigator 4) Subjects with ECOG performance status 0 - 1 or Karnofsky performance status 70 or higher 5) Subjects who have appropriate hematological, liver, renal, and blood coagulation functions confirmed based on the following criteria at screening: 6) Subjects who have appropriate cardiac and pulmonary functions confirmed based on the following criteria at screening: 7) Subjects who agree to use sunscreen during the clinical study period. 8) Subjects (or the subject's legal representative) who voluntarily consent and provide written informed consent to participate in this clinical study.\n\n9\\) (Only for Phase 2a) Subjects with one or more measurable NF2-related tumors confirmed on MRI at screening\n\nExclusion Criteria:\n\n1\\) Subjects who have the following past or current medical history confirmed during screening:\n\n(1) Malignant tumor requiring treatment (chemotherapy or radiotherapy) or with disease progression within 2 years prior to screening (2) The following heart-related history\n\n* Uncontrolled hypertension at screening (DBP ≥100 mmHg or SBP ≥160 mmHg despite treatment)\n* Acute coronary syndrome (ACS) within 24 weeks of baseline, clinically significant arrhythmia, cardiomyopathy, unstable angina, NYHA II-IV heart failure, or severe valvular heart disease\n\n  1. Interstitial lung disease or pulmonary fibrosis\n  2. Cystitis or urinary obstruction within 12 weeks prior to screening\n  3. Blood coagulation disorder\n  4. Severe or active infectious disease requiring antibiotics, antivirals, etc. within 4 weeks prior to screening\n  5. Gastrointestinal disease that currently makes oral administration difficult or may affect absorption (e.g., celiac disease, Crohn's disease, intestinal resection)\n  6. Other diseases that are sufficient to affect the clinical study results at the investigator's discretion.\n\n  2\\) Subjects who have confirmed or need the following drug treatments:\n  1. Chemotherapy, immunotherapy, or myelosuppressive chemotherapy within 4 weeks prior to screening (but, within 6 weeks prior to screening for nitrosourea agents or mitomycin C)\n  2. Monoclonal antibody therapy within 12 weeks prior to screening (but, allowing if more than 3 half-lives have elapsed); stem cell transplantation (but, allowing if there is no evidence of active graft-versus-host disease and more than 12 weeks have elapsed since transplantation)\n  3. Other investigational drugs or devices within 4 weeks prior to screening\n  4. Corticosteroids such as prednisone and prednisolone within 1 week prior to screening (but, allowing if treated with low doses)\n  5. Substrate of strong inhibitor, inducer, or transporter (OCT2, MATE1, MATE2-K) of CYP enzymes (CYP2C8, CYP3A) (but, allowing only if more than 5 times the half-life from baseline has elapsed) 3) Subjects who performed a major surgery within 4 weeks prior to screening (but, allowing minor surgical procedures such as catheter replacement therapy and local biopsy).\n\n  4\\) Subjects who received radiation therapy for the purpose of treating tumors due to NF2 within 24 weeks prior to screening or who require total body irradiation during the clinical study period.\n\n  5\\) Subjects with prosthetics or orthopedic devices that may interfere with the volumetric analysis of target lesions via MRI.\n\n  6\\) Subjects with a known severe hypersensitivity to PRG-N-01 or a concomitant medication or the ingredients or a history of allergic reactions to compounds of similar chemical or biological composition.\n\n  7\\) Female subjects who are pregnant or breastfeeding 8) Women of childbearing potential or men who are unwilling to use an appropriate method of contraception from the date of written consent to 12 weeks after the last dose of PRG-N-01.\n\n  9\\) Other subjects who are deemed unsuitable for participation in this clinical study at the investigator's discretion",{"count":51,"type":23},25,[26,53],"PHASE2","The goal of this clinical trial is to learn if Trineumin(Code name:PRG-N-01) works to treat Neurofibromatosis Type II(NF2) in adults. It will also learn about the safety and tolerability and toxicity of PRG-N-01. The main questions it aims to answer are:\n\n* What dose was determined as the Maximum Tolerated Dose (MTD) of Trineumin?\n* What dose was explored as the optimal effective dose of Trineumin based on radiographic response?\n* Does Trineumin reduce tumor size or improve participants' quality of life, including hearing function?\n* What medical problems do participants have when taking Trineumin?\n\nParticipants will:\n\n* Take Trineumin every day for 96 weeks\n* Visit the clinic once 1, 4, 8, 12, 18week and every 12 weeks and for checkups and tests",[56,57],"Neurofibromatosis Type II","NF2","NOT_YET_RECRUITING","2026-01-21",{"date":61,"type":34},"2026-01-23",{"date":63,"type":23},"2026-07",{"date":65,"type":23},"2028-07",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":24,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100504351","phase-2-phase-2-open-label-study-to-evaluate-the-safety-and-tolerability-of-progerinin-in-werner-syndrome-100504351","NCT05847179","Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin in Werner Syndrome","A Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin for the Treatment of Bone Mineral Density (BMD) Loss in Subjects With Typical Werner Syndrome","Inclusion Criteria:\n\n1. Subjects must be at least ≥ 18 years of age.\n2. Subjects should have a confirmed diagnosis of typical Werner syndrome by genetic analysis.\n3. Subjects should be osteopenic (T-score between -1.0 and -2.5) or have confirmed osteoporosis (Tscore ≤ -2.5) at screening\u002Fbaseline. Subjects may continue to receive bone supplements (e.g., bisphosphonates, calcium supplements, Vitamin D supplements, etc.) as appropriate per standard of care throughout the study.\n4. Male or non-pregnant, non-lactating female.\n5. Subjects screening blood chemistry inclusive of metabolic panel, hematology, and urine analysis results should be acceptable to the investigator.\n6. Negative pregnancy test for female subjects as described below. Women of child bearing potential (WOCBP) and Women not of child-bearing potential are eligible to participate. Both women of childbearing potential and women of non-child-bearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 90 days after last treatment.\n\n   Acceptable methods of contraception include abstinence, female subject\u002Fpartner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject\u002Fpartner's use of an intrauterine device (IUD), or if the female subject\u002Fpartner is surgically sterile or two years post-menopausal. All male subjects\u002Fpartners must agree to use a In addition, subjects may not donate sperm for the duration of the study and for 90 days after last treatment.\n\n   Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test at baseline within the one (1) week prior to the first study medication administration. Every six weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed.\n7. Provide signed written informed consent and willingness, ability to comply with study requirements.\n8. Subject must have a projected life expectancy of ≥ 12 months in the opinion of the Investigator.\n\nExclusion Criteria:\n\n1. Subject with clinical signs seen at screening are at the final stage of Werner syndrome progression, and completion of the study is difficult to be assessed, including:\n\n   * Subjects who received continuous or intermittent home oxygen therapy for 6 months before obtaining consent\n   * Subjects who received at least 2 hospitalizations for pneumonia during the 12 months prior to obtaining consent\n   * Subjects who have at least 10% net weight loss and have not recovered. This includes significant net weight loss over the last six months.\n2. Subjects with significant dehydration as judged by the principal investigator.\n3. Subjects with pericardial fluid, ascites and pleural effusion.\n4. Therapy with investigational drugs within 30 days of beginning study medication.\n5. History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (e.g., breast, prostate) for which the subject has been disease-free for at least 3 years.\n6. Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for the study.\n7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous (IV) treatment for infection(s).\n8. Subjects with known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV).\n9. Subjects with a history of serious drug hypersensitivity or allergic reaction such as anaphylaxis or any component of the formulation.\n10. Clinically significant bleeding within 2 weeks prior to baseline (e.g., gastrointestinal \\[GI\\] bleeding, intracranial hemorrhage).\n11. Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit and for the duration of the trial.\n12. Pregnant or lactating women.\n13. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days prior to baseline or anticipated surgery during the study period.\n14. Inability to return for scheduled treatment and assessments.\n15. Subjects that require concomitant use of any medications or substances that are strong inhibitors or inducers of CYP2D6 or CYP2C8",{"count":75,"type":23},5,[53],"This is a Phase 2, open-label study to A Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin for the Treatment of Bone Mineral Density (BMD) Loss in Subjects with Typical Werner Syndrome.\n\nThere will be up to 5 subjects that will receive treatment with Progerinin twice daily for approximately 1 year.",[79],"Werner Syndrome",{"date":61,"type":34},{"date":63,"type":23},{"date":83,"type":23},"2027-12",{"name":40,"class":41},""]