[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Inno Medicine Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,72,95,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100633001","phase-2-a-phase-2b-clinical-trial-of-yn001-in-adults-with-coronary-atherosclerosis-100633001",false,"NCT07521007","A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis","A Randomized, Multicenter, Double-Blind, Parallel, Placebo-controlled Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Adults With Coronary Atherosclerosis","PURIFY-TIMI 81","Inclusion Criteria:\n\n1. Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.\n2. Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).\n3. Participants must satisfy either of the following criteria:\n\n1\\) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening\u002Fbaseline, as evidenced by:\n\n1. A history of Type 2 diabetes requiring treatment with medication,\n2. Aged \\> 55 years (women) or \\> 50 years (men),\n3. 2 or more of the following atherosclerosis risk factors:\n\n   * Current cigarette smoker\n   * Hypertension\n   * Estimated glomerular filtration rate (eGFR) 45 to 60 ml\u002Fmin\u002F1.73m2\n\n     4\\. Known coronary atherosclerosis as evidenced through coronary angiography or CCTA. The following criteria must be met on the core lab CCTA interpretation for the patient to be enrolled: at least one epicardial coronary artery with a lumen stenosis of 25% to 69%, total coronary NCPV is at least 75 mm3, Detectable low-attenuation composition in one or more individual plaques.\n\n     5\\. Female participants must be non-pregnant and non-lactating\n\n     6\\. Willing and able to comply with the requirements of protocol to the best of the participant's and investigator's knowledge.\n\nExclusion Criteria:\n\n1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.\n2. Previously received YN001.\n3. Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period\n4. Contraindication for CCTA\n5. 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.\n6. Acute MI that occurred within 4 weeks prior to randomization.\n7. PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization.\n8. Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization.\n9. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months.\n10. Prior coronary artery bypass graft (CABG), aortic root surgery with coronary reimplantation, left ventricular assist device (LVAD) placement, surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR), or heart transplantation, or a plan to undergo these procedures (CABG, aortic root surgery with coronary reimplantation, LVAD placement, SAVR, TAVR, or heart transplantation) during the study.\n11. New York Heart Association class III or IV or last known left ventricular ejection fraction (LVEF) was \\\u003C40%.\n12. Carotid endarterectomy or stenting, peripheral arterial revascularization, or abdominal aortic aneurysm repair within 4 weeks prior to randomization.\n13. History of myopathy or myositis, or susceptibility to myopathy\u002Frhabdomyolysis (e.g., family history of hereditary myopathy, etc.).\n14. History of severe myalgia attributed to statin therapy or other significant concern about statin side effects.\n15. Known gastrointestinal ulcers, inflammatory bowel disease, or gastrointestinal\u002Frectal bleeding within 6 months prior to randomization.\n16. Evidence of unresolved major diseases 2 weeks prior to randomization or planned major surgery during the study that, in the investigator's judgement, may interfere with the investigational product administration or trial assessments.\n17. Presenting with history of malignancy (except in participants who have been disease-free \\>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).\n18. Presence of any type of autoimmune disease.\n19. Allergy to multiple foods or drugs or known sensitivity to any components to be administered during dosing.\n20. Life expectancy is less than 1 year.\n21. Systolic blood pressure of ≥ 160 mmHg at final screening despite antihypertensive therapy.\n22. Triglycerides ≥ 400 mg\u002FdL (4.5 mmol\u002FL) at final screening.\n23. LDL-C \\> 100 mg\u002FdL (2.6 mmol\u002FL) at final screening.\n24. Active liver disease or hepatic dysfunction defined by any of alanine aminotransaminase (ALT), aspartate aminotransferase (AST), \\> 3 times upper limit of normal (ULN), or total bilirubin \\> 2 times ULN at final screening.\n25. Presence of renal dysfunction, defined by eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2.\n26. Untreated or inadequately treated hypothyroidism.\n27. Poorly controlled Type 2 diabetes mellitus.\n28. A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).\n29. Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the participant to participate in this study.","ALL","18 Years","80 Years",{"count":21,"type":22},456,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.",[28,29],"Atherosclerosis","Coronary Artery Disease",[31,32],"Plaque regression","Plaque stabilization","NOT_YET_RECRUITING","2026-04-02",{"date":36,"type":37},"2026-04-09","ACTUAL",{"date":39,"type":22},"2026-04-30",{"date":41,"type":22},"2029-03-31",{"name":43,"class":44},"Beijing Inno Medicine Co., Ltd.","INDUSTRY",13,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100569936","phase-2-yn001-004-in-patients-with-coronary-atherosclerosis-in-australia-100569936","NCT06700720","YN001-004 in Patients With Coronary Atherosclerosis in Australia","A Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of YN001 in Patients With Coronary Atherosclerosis in Australia","Inclusion Criteria:\n\n1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.\n2. Male or female Australia patients between 18 and 75 years.\n3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).\n4. Female patients must be non-pregnant and non-lactating, and females of childbearing potential (including a female partner of a male patient) must agree to use 1 effective contraception method from the screening period to 3 months after receiving their last dose of the study drug. In addition, male patients must be willing to refrain from sperm donation during this time.\n5. Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.\n\nExclusion Criteria:\n\n1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.\n2. Previously received YN001.\n3. Any type of vaccination within 4 weeks prior to randomization.\n4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).\n5. Multi-vessel severe disease.\n6. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.\n7. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia.\n8. Prior treatment with CABG, heart transplantation, SAVR\u002FTAVR, etc., or CABG, heart transplantation, SAVR\u002FTAVR, etc., is required or planned during the study.\n9. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.\n10. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) \\\u003C40%.\n11. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).\n12. Presenting with history of myopathy\u002Fmyalgia, or susceptible to myopathy\u002Frhabdomyolysis.\n13. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to randomization.\n14. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.\n15. Presenting with history of malignancy (except in patients who have been disease-free \\>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).\n16. Presence of any type of autoimmune disease.\n17. Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing\n18. Life expectancy is less than 1 year.\n19. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.\n20. Known familial hypercholesterolemia\n21. Triglycerides≥400 mg\u002Fdl (4.5 mmol\u002Fl) at final screening.\n22. Active liver disease or hepatic dysfunction defined by any of ALT, AST, or total bilirubin \\> 2 times upper limit of normal (ULN) at final screening.\n23. Presence of renal insufficiency.\n24. Untreated or inadequately treated hypothyroidism defined by thyroid stimulating hormone (TSH) \\> 1.5 times ULN at final screening.\n25. Poorly controlled (defined by HbA1c \\> 9%) type 2 diabetes mellitus.\n26. A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).\n27. Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per day over the preceding year.\n28. Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the patient to participate in this study.","75 Years",{"count":55,"type":22},24,[25],"This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed tomography angiography (CCTA)",[29,59],"Coronary Atherosclerotic Disease",[61,31],"Coronary Atherosclerosis","RECRUITING","2026-02-12",{"date":65,"type":37},"2026-02-17",{"date":67,"type":22},"2026-02",{"date":69,"type":22},"2026-06",{"name":43,"class":44},7,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":18,"maxAge":53,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100616878","phase-2-phase-iia-clinical-trial-of-yn001-in-patients-with-atherosclerotic-cardiovascular-and-cerebrovascular-diseases-and-erectile-dysfunction-100616878","NCT07311330","Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction","A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction","Inclusion Criteria:\n\n1. Fully understand the purpose, nature, method and possible adverse reactions of the study, voluntarily participate as a subject in the study, and sign the informed consent form (ICF) before performing any study-related assessments;\n2. One or both of the previous history of coronary atherosclerosis, coronary heart disease, cerebral atherosclerosis, stroke, ischemic attack, carotid atherosclerosis, peripheral arterial disease, or plaque in at least one vessel of the carotid, subclavian, or femoral arteries as detected by peripheral arterial ultrasound .\n3. Clinical diagnosis of mild to moderate erectile dysfunction, IIEF-5 questionnaire score ≤ 21 points, duration of at least 3 months (subject to signing informed consent);\n4. Subjects (including partners) guarantee that they have no plans to father a child or donate sperm during the study and for 3 months after the last dose and voluntarily take appropriate contraceptive measures;\n5. After the screening run-in period, the following three conditions were met simultaneously:\n\n1\\) At least 4 attempts at sexual intercourse during the run-in period; 2) Has a failure rate of ≥ 50% of attempts to intercourse (failure to intercourse is defined as having at least one of the three questions answered on the SEP); 3) IIEF-EF score ≥ 11 and ≤ 25.\n\nExclusion Criteria:\n\n1. Patients with erectile dysfunction caused by other sexual dysfunction diseases (such as ejaculatory dysfunction) or endocrine diseases that are not controlled (after medication) (such as hypogonadism, hyperthyroidism\u002Fhypothyroidism, pituitary tumor, etc.);\n2. History of stroke within 6 months prior to informed consent;\n3. Patients who have received or are receiving anti-androgen therapy, or have a history of androgen replacement therapy and are stable for less than 3 months;\n4. Patients scheduled for CABG, PCI, heart transplantation, SAVR\u002FTAVR during the study period;\n5. Patients with unstable diabetic blood glucose control, and fasting blood glucose more than 15 mmol\u002FL, or accompanied by diabetic complications (diabetic nephropathy, peripheral neuropathy);\n6. Combined with abnormal liver function, defined as AST and\u002For ALT more than 2 times the upper limit of normal;\n7. Combined with severe renal dysfunction, defined as glomerular filtration rate \\\u003C 30.0 mL\u002Fmin\u002F1.73m ² calculated by CKD-EPI formula;\n8. Subjects who have used vacuum aspiration (VCD), intracavernosal injection (ICI) therapy or other drugs to treat erectile dysfunction and cannot interrupt the above treatment during the study;\n9. Patients who have severe central nervous system injury (cerebral vascular diseases such as cerebral hemorrhage or ischemia, brain inflammatory diseases such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury), or peripheral nervous system injury or lesions within 6 months before signing the informed consent;\n10. History of myopathy\u002Fmyalgia, or susceptibility to myopathy\u002Frhabdomyolysis (e.g., family history of hereditary myopathy, previous use of HMG-CoA reductase inhibitors in combination with fibrates, etc.);\n11. Presenting with hypothyroidism, defined as marked TSH elevations (usually \\> 1.5 ULN) associated with decreases in free T4 (FT4) ;\n12. Patients with a history of drug abuse, drug abuse and alcoholism (tolerance, withdrawal, impaired control of drinking behavior) in the past 1 year;\n13. Participation in another interventional clinical investigator within 1 month prior to informed consent;\n14. Patients who, in the opinion of the investigator, are not suitable for this study.","MALE",{"count":81,"type":22},40,[25],"This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction",[85,86],"Atherosclerotic Cardiovascular Disease (ASCVD)","Erectile Dysfunction","2025-12-21",{"date":89,"type":37},"2025-12-30",{"date":91,"type":22},"2026-01-31",{"date":93,"type":22},"2026-11-14",{"name":43,"class":44},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":116,"locationsCount":4},"100616702","phase-1-phase-1-study-of-the-safety-and-pharmacokinetics-of-yn001-with-rosuvastatin-in-healthy-chinese-subjects-100616702","NCT07309042","Phase 1 Study of the Safety and Pharmacokinetics of YN001 With Rosuvastatin in Healthy Chinese Subjects","A Randomized, Open-label Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of the Combination of YN001 and Oral Rosuvastatin Calcium Tablets in Healthy Chinese Individuals","Inclusion Criteria:\n\n1. Fully understand the purpose, characteristics, research methods and potential adverse reactions of this study, voluntarily participate in the study as a subject, and sign the Informed Consent Form (ICF) before any assessments are performed.\n2. Healthy Chinese male and female subjects aged 18 to 55 years (inclusive, based on the age at the time of signing the ICF).\n3. Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) ranging from 18 to 28 kg\u002Fm² (including the critical values).\n4. Judged by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) and viral serological test results (normal or abnormal without clinical significance) to be in good general health.\n5. Female subjects must be non-pregnant and non-lactating; female subjects of childbearing potential (including female partners of male subjects) must agree to use effective contraceptive methods such as abstinence, condoms, intrauterine devices in use, double barrier methods (e.g., condoms plus diaphragms) from the screening period until 6 months after receiving the last dose of the study drug.\n6. Willing and able to comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Participation in other clinical trials within 3 months prior to the first dose or within 5 half-lives (whichever is longer). Subjects who withdrew from the study before receiving the study drug (i.e., not administered the drug) are eligible for enrollment.\n2. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 2 weeks prior to the first dose, or receipt of any type of vaccination.\n3. Consumption of diets that may affect the in vivo metabolism of drugs (including grapefruit or grapefruit products, pitaya, mango, etc.) within 7 days prior to screening, engagement in strenuous exercise, or consumption of other diets that the investigator deems may affect the absorption, distribution, metabolism, or excretion of drugs.\n4. History of severe food allergies (e.g., anaphylactic shock). Mild food allergies such as lactose intolerance and glucose intolerance are not excluded.\n5. Allergy to multiple drugs, history of allergy to rosuvastatin, or history of allergic reactions to any component of the study drugs.\n6. Known presence of clinically significant abnormal diseases or factors, including but not limited to clinically significant abnormalities in abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, bilateral kidneys, ureters, urinary bladder), chest posteroanterior radiography, etc.; or clinically significant diseases (including but not limited to diseases of the digestive system, circulatory system, respiratory system, endocrine system, urinary system, immune system, nervous system, and mental and psychological diseases) shown by other clinical findings within 6 months prior to screening.\n7. History of myopathy\u002Fmyalgia, or predisposition to myopathy\u002Frhabdomyolysis (e.g., family history of hereditary myopathy, previous combined use of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors and fibrates, etc.).\n8. Presence of hypothyroidism or hyperthyroidism.\n9. History of acute or chronic bronchospastic diseases (including asthma, chronic obstructive pulmonary disease, whether treated or not) or heart failure, myocardial infarction, with a history of onset or recurrence within the past 3 years.\n10. Known history of inflammatory bowel disease, ulcers, gastrointestinal bleeding, or rectal bleeding within 6 months prior to the first dose.\n11. History of pancreatic injury or pancreatitis within 6 months prior to dosing.\n12. Presence of symptoms of urinary tract obstruction or dysuria.\n13. History of autonomic nervous system disorders (e.g., recurrent syncope, palpitations, etc.), with a history of onset or recurrence within the past 3 years.\n14. Suffering from a major unhealed disease within 2 weeks prior to the first dose; or expected to undergo major surgery during the study period.\n15. History of renal impairment, manifested by clinically significant abnormalities in creatinine, blood urea nitrogen (BUN) and\u002For urea levels, or clinically significant abnormalities in urine components (e.g., proteinuria).\n16. Presence of liver disease or liver injury, or abnormal liver function test results. Subjects who meet any of the following criteria must be excluded from the study:\n\n    1. Any one of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum bilirubin exceeds 1.5 times the upper limit of normal (ULN).\n    2. Any two or more of ALT, AST, or serum bilirubin exceed the upper limit of normal (ULN).\n17. History of clinically significant electrocardiogram (ECG) abnormalities; or presence of any of the following abnormalities during screening or baseline period:\n\n    1. QTcF (males) \\> 470 milliseconds (msec).\n    2. QTcF (females) \\> 480 milliseconds (msec). (Corrected by the Frederica formula, calculated as QTcF = QT\u002F(RR⁰·³³))\n18. Screening test shows hemoglobin level \\\u003C 120 grams per liter (g\u002FL) in males and \\\u003C 110 grams per liter (g\u002FL) in females.\n19. Blood donation or blood loss exceeding 400 milliliters (mL) within 3 months prior to screening.\n20. Smoking more than 10 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening.\n21. History of drug abuse within 12 months prior to screening; or use of any illegal drugs within 3 months prior to screening; or positive results in drug abuse tests (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, morphine, etc.) during screening.\n22. Weekly alcohol consumption exceeding 14 standard drinking units (1 standard drinking unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine) within 3 months prior to screening; or consumption of alcohol-containing products within 48 hours prior to the first dose; or positive results in breath alcohol test during the baseline period.\n23. Positive results in tests for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.\n24. The investigator deems the subject unsuitable for participation in the study due to any other diseases or conditions.",true,"55 Years",{"count":55,"type":22},[106],"PHASE1","The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials.",[109,110],"Atherosclerotic Cardiovascular Diseases","Cerebrovascular Diseases","2025-12-15",{"date":89,"type":37},{"date":114,"type":22},"2025-12",{"date":67,"type":22},{"name":43,"class":44},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":102,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100607617","phase-1-a-pharmacokinetic-study-of-yn001-in-healthy-participants-100607617","NCT07190885","A Pharmacokinetic Study of YN001 in Healthy Participants","Inclusion Criteria:\n\n1. Written informed consent must be obtained before any assessment is performed.\n2. Healthy male and female adults aged from 18 to 65 years of age (inclusive) at time of Screening, and in good health as determined by no clinically significant (as judged by the PI\u002Fdelegate) past medical history, physical examination, and vital signs, electrocardiogram (ECG), and laboratory tests at Screening and Baseline (Day -1).\n3. Vital signs (systolic and diastolic blood pressure and pulse rate) measurements within the below ranges at Screening and Baseline (Day -1):\n\n   * tympanic body temperature between 35.5-37.7 °C\n   * systolic blood pressure, 90-140 mm Hg (inclusive)\n   * diastolic blood pressure, 40-95 mm Hg (inclusive)\n   * pulse rate, 40-100 bpm (inclusive)\n4. Weigh at least 50 kg and have a body mass index (BMI) within the range of 18-32 kg\u002Fm2 at Screening and Baseline (Day -1).\n5. Meets contraception requirements.\n6. Willing and able to comply with the study requirements and restrictions.\n\nExclusion Criteria:\n\n1. Received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.\n2. Use of any prescription drugs, over the counter (OTC) medication, herbal supplements, dietary supplements (vitamins included), any type of vaccine within two weeks prior to the study drug administration, unless deemed acceptable by the Principal Investigator (or delegate) and agreement with the Sponsor.\n3. Fasting triglyceride concentration \\>2.8 mmol\u002FL at Screening or Baseline (Day -1).\n4. A history of clinically significant ECG abnormalities, or any ECG abnormalities at Screening or Baseline (Day -1).\n5. Pregnant or nursing (lactating) women.\n6. Average use of more than 5 cigarettes or equivalent nicotine containing products per week and\u002For unwilling to abstain from such products 7 days prior to study administration through until Day 15. Positive urine cotinine test at Baseline (Day -1); repeat testing may be permitted at PI\u002Fdelegate discretion.\n7. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by positive results for alcohol or drugs conducted at Screening and\u002For Baseline (Day -1). Alcohol abuse is defined as consumption of 14 or more standard drinks per week (where 1 unit = 375 mL of beer \\[3.5% alc\u002Fvol\\], 30 mL of 40% spirit or a 100 mL glass of wine \\[13%\\]). Any THC-containing products should not be used at least 7 days prior to Screening through until completion of Day 15.\n8. A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test result at Screening.\n9. History of myopathy\u002Fmyalgia, or susceptible to myopathy\u002Frhabdomyolysis (e.g., hypothyroidism, family history of hereditary myopathy, previous muscle toxicity with HMG CoA reductase inhibitors or fibrates).\n10. Multiple drug allergies, or history of allergic reactions to study drug or any components of the study drug.\n11. Donation or loss of more than 400 ml of blood within 3 months prior to study drug administration.\n12. Plasma donation (\\> 100 ml) within 60 days prior to first dosing.\n13. Hemoglobin levels below 120 g\u002FL at Screening or Baseline (Day -1).\n14. Recent (within the last 3 years) and\u002For recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).\n15. Recent (within the last 3 years) and\u002For recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), or cardiac dysfunction or myocardial infarction.\n16. History of significant food allergies (e.g. anaphylactic reactions). Mild (non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance\u002Fglucose intolerance are permitted.\n17. Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study. The Investigator should make this determination in consideration of the participant's medical history and\u002For clinical or laboratory evidence of any of the following:\n\n    1. Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding in the last 6 months.\n    2. Pancreatic injury or pancreatitis in the last 6 months.\n    3. Liver disease or liver injury as indicated by abnormal liver function tests at Screening or Baseline (Day -1) such as SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase (ALP), or total bilirubin. The Investigator should be guided by the following criteria:\n\n       • Any single parameter of ALT, AST, GGT, ALP, or total bilirubin must not exceed 1.5 x upper limit of normal (ULN).\n    4. History or presence of impaired renal function as indicated by abnormal creatinine and\u002For urea values (e.g., eGFR\\\u003C90 mL\u002Fmin\u002F1.73 m2 (calculated by CKD-EPI equation), or abnormal urinary constituents (e.g., albuminuria), deemed clinically significant by the PI\u002Fdelegate at Screening or Baseline (Day -1).\n    5. Evidence of urinary obstruction or difficulty in voiding at Screening.\n18. Significant illness resolved within two weeks prior to dosing, which may affect the study drug administration and safety assessments in the opinion of the PI\u002Fdelegate.\n19. Any other medical condition or social circumstance, which in the opinion of the PI\u002Fdelegate would impede compliance with or hinder completion of the study or otherwise deem the participant unsuitable for inclusion.","65 Years",{"count":55,"type":22},[106],"This is a Phase 1, single-center, open-label study designed to evaluate the pharmacokinetics (PK), safety, and immunogenicity following a single dose administration in healthy adult volunteers.",[128],"Healthy Volunteers","2025-12-11",{"date":131,"type":37},"2025-12-18",{"date":133,"type":37},"2025-11-18",{"date":135,"type":22},"2026-02-18",{"name":43,"class":44},1,""]