[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Vimgreen Pharmaceuticals, Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100648634","phase-2-phase-iib-clinical-trial-to-evaluate-the-efficacy-and-safety-of-vg081821ac-tablets-in-patients-with-early-to-mid-stage-parkinsons-disease-100648634",false,"NCT07725562","Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of VG081821AC Tablets in Patients With Early to Mid-stage Parkinson's Disease","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease","Inclusion Criteria:\n\n(1). Male or female aged 18 ≤ Age ≤ 80 at the time of signing the informed consent. (2). Diagnosed with Parkinson's disease per the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), and time from initial diagnosis ≤ 7 years. (3). Modified Hoehn-Yahr scale rated as 1\\~3 (inclusive) at screening. (4). MDS-UPDRS Part III score ≥ 22 at screening. (5). Have not taken anti-Parkinson drugs containing levodopa within 4 weeks prior to screening \\[see main text section 5.7.1\\] (Note: Patients who have previously taken levodopa-containing anti-Parkinson drugs can participate in this trial after a 4-week washout period). (6). Patients receiving amantadine and\u002For anticholinergic drugs prior to screening must have been on a stable treatment regimen for at least 4 weeks prior to screening, and the dose must not change during the study. (7). Women of childbearing potential must have a negative pregnancy test result at screening, and the participant must agree to use approved contraceptive measures throughout the study period. (8). Must provide written informed consent and be willing and able to comply with the trial protocol (e.g., able to understand and complete questionnaires, follow the visit schedule, and use the medication).\n\nExclusion Criteria:\n\n(1). Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: current diagnosis of active epilepsy; history of hemolytic anemia, pulmonary embolism, respiratory depression, dementia, active psychiatric disease, severe depression, or malignant tumor. (2). History of congestive heart failure (New York Heart Association functional class 3 or 4) or known left ventricular ejection fraction \\\u003C30%. (3). History of angina pectoris, myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, peripheral arterial bypass surgery, transient ischemic attack (TIA), or stroke within 3 months prior to screening. (4). History of arrhythmia or presence of uncontrolled arrhythmia, including but not limited to: atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, and ECG indicating QTc interval prolongation (defined as male (QTc) \\> 450 ms, female (QTc) \\> 470 ms); \\[Fridericia formula: QTc=QT\u002F(RR\\^0.33), where RR represents the standard heart rate value, calculated by dividing 60 by the heart rate\\]. (5). Use of dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase (COMT) inhibitors, adenosine A2A receptor antagonists, or drugs with dopamine receptor antagonist effects within 4 weeks prior to screening \\[see main text section 5.7.1\\]. (Note: For newly diagnosed patients undergoing an acute dopaminergic challenge test-i.e., taking a single dose of levodopa \\[e.g., Madopar\\] or dopamine agonist \\[e.g., Apomorphine\\]-they can be enrolled after a 3-day washout period). (6). History of drug or other allergies where the investigator considers participation in this study to be of high risk, or previous allergic reactions to adenosine A2A receptor antagonists, or suspected by the investigator to be allergic to the study drug or any of its components. (7). Plan to take drugs that are inhibitors or inducers of efflux transporters (P-gp, BCRP) during the study period. (8). Suffering from uncontrolled hypertension (treated or untreated) at screening, defined as systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg. (Note: After establishing good blood pressure control within a reasonable timeframe, the investigator may permit re-measuring of blood pressure up to the baseline visit, at their discretion). (9). Presence of clinically significant hepatic impairment (defined as total bilirubin and\u002For direct bilirubin, alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) above the upper limit of the reference range, and deemed clinically significant by the investigator). (10). Presence of any of the following: positive Hepatitis B surface antigen; positive Hepatitis C virus antibody; positive Hepatitis E virus antibody; positive Human Immunodeficiency Virus (HIV) test; positive Treponema pallidum test. (11). Previous non-response to high-dose levodopa (excluding cases of malabsorption) or previous non-response to adequate dopaminergic therapy. (12). Presence of clinically significant renal impairment (creatinine clearance Ccr \\\u003C30mL\u002Fmin), calculated at screening using the Cockcroft-Gault formula: Ccr (mL\u002Fmin) = (140 - Age) × Weight (kg) \u002F \\[72 × Serum Creatinine (SCr) (mg\u002FdL)\\] (Female × 0.85) or Ccr (mL\u002Fmin) = (140 - Age) × Weight (kg) \u002F \\[0.814 × Serum Creatinine (SCr) (μmol\u002FL)\\] (Female × 0.85). (13). Investigator judges the participant to be at risk for suicide, or if the participant answers \"yes\" to Question 4 and\u002For Question 5 of the Suicidal Ideation subscale, or any question on the Suicidal Behavior subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening. (14). Investigator judges the participant to have severe psychiatric abnormalities (anxiety, depression), with a Hamilton Depression Rating Scale-17 (HAMD-17) score \\>23, or a Hamilton Anxiety Rating Scale (HAMA) score \\>21 at screening. (15). Participant has significant cognitive impairment or dementia, including the following scenarios: Illiterate participants (uneducated) with an MMSE score ≤19 at screening; Primary school participants (education ≤6 years) with an MMSE score ≤22 at screening; Middle school and above participants (education \\>6 years) with an MMSE score ≤23 at screening. (16). History of surgical treatment for Parkinson's disease. (17). Use of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, biofeedback therapy, acupuncture, traditional Chinese medicine, and other traditional rehabilitation methods within 4 weeks prior to screening (Note: Patients can participate in this trial after a 4-week washout period). (18). History of heavy alcohol consumption for more than 3 consecutive months within 1 year prior to screening, defined as: female participants drinking an average of \\>20 g of alcohol daily (calculated as pure alcohol; 20 g is roughly equivalent to two 300 mL glasses of beer, 40 mL of spirits, or 140 mL of wine), and male participants drinking an average of \\>30 g of alcohol daily (calculated as pure alcohol; 30 g is roughly equivalent to three 300 mL glasses of beer, 60 mL of spirits, or 210 mL of wine), or inability to reliably quantify alcohol consumption according to the investigator's judgment. (19). History of excessive tea and\u002For coffee consumption within the past 4 weeks, or anticipated excessive consumption during the clinical trial period. (Excessive tea consumption is defined as 4 or more cups a day, 1 cup = 250 mL; second or third steepings without adding new leaves still count as 1 cup total, not two or three. Excessive coffee consumption is defined as 2 or more cups a day, 1 cup = 250 mL; for participants who do not drink coffee every day, 2 cups per day is permissible for one day a week, but no more than 2 cups; and the defined consumption limit must not be exceeded throughout the entire trial). (20). Active substance abuse (including inhaled or injected drugs) within 1 year prior to screening. (21). Participated in another drug clinical trial (meaning received investigational drug treatment) within 3 months prior to randomization. (22). Any other condition where the investigator considers the participant unsuitable for this study.","ALL","18 Years","80 Years",{"count":20,"type":21},152,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. The main goal is to measure changes in movement symptoms using a standard rating scale called the MDS-UPDRS Part III (Motor Examination). This scale evaluates how well participants can move, walk, and perform daily activities. The study will compare the scores before and after 12 weeks of treatment to see if VG081821AC improves movement symptoms better than the placebo. Currently, levodopa is the most common treatment for Parkinson's disease, but it can cause side effects over time. If VG081821AC works well, it could offer a new treatment option for people in the early to mid-stages of Parkinson's disease who want to delay or avoid starting levodopa. A total of 152 adults (aged 18-80 years) will be enrolled in this trial in China. Participants will be randomly assigned (like flipping a coin) to one of four groups:\n\n* VG081821AC 25 mg (taken twice daily)\n* VG081821AC 50 mg (taken twice daily)\n* VG081821AC 75 mg (taken twice daily)\n* Placebo (a pill with no active drug, taken twice daily)\n\nParticipants will visit the study center 8 times to have their movement symptoms, safety, and overall health checked.",[28],"Parkinson Disease (PD)",[30,31,32,33,34,35,36],"A2A receptor antagonist","Adenosine A2A antagonist","VG081821AC","VG081821","KW6002","Istradefylline","Nourianz","RECRUITING","2026-07-20",{"date":40,"type":41},"2026-07-24","ACTUAL",{"date":43,"type":41},"2026-07-17",{"date":45,"type":21},"2027-10-31",{"name":47,"class":48},"Zhejiang Vimgreen Pharmaceuticals, Ltd.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100522349","phase-1-a-phase-i-study-of-single-and-multiple-doses-of-vg290131-in-healthy-subjects-100522349","NCT06081465","A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects","A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered VG290131 in Healthy Adult Subjects","Inclusion Criteria:\n\nA subject will be eligible for inclusion in this study only if all of the following criteria are met:\n\n1. Willing to comply with protocol required visit schedule and visit requirements and provide written ICF;\n2. Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF;\n3. Body mass index between 18.0 and 32.0 kg\u002Fm2, inclusive;\n4. Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG;\n5. Male subjects must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner, if of childbearing potential, from the signing of ICF to 3 months after the last dose of IMPs and refrain from donating sperm during this period. These contraception requirements do not apply if the male subject is in an exclusively same sex relationship;\n6. Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n   * Women of non-childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle stimulating hormone \\[FSH\\] level ≥40 mlU\u002FmL);\n   * WOCBP and agree to practice true abstinence or agrees to use a highly effective method of contraceptions consistently from the signing of ICF to 3 months after the last dose of investigational medicinal products \\[IMPs\\] and refrain from donating eggs during this period. And WOCBP must have a negative serum and\u002For urine pregnancy test result within 7 days prior to the first dose of IMPs.\n   * Subject is in an exclusively same-sex relationship.\n\nExclusion Criteria:\n\nA subject meeting any of the following exclusion criteria will not be allowed to participate in this study:\n\n1. Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the VG290131; history of other significant allergies or anaphylaxis, as determined by the investigator;\n2. Considered by the investigator to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations;\n3. Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention;\n4. History of stomach or intestinal surgery or resection diseases including but not limited to, gastric band\u002Fgastric resection and\u002For intestinal resection and\u002For duodenal disease (i.e. celiac disease) which may potentially alter absorption and\u002For excretion of VG290131 (except for an appendectomy);\n5. Used drugs or substances known to be inducers or inhibitors of cytochrome P450 enzymes or P-glycoprotein (P-gp) substrates within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;\n6. Used prescription or over-the-counter (OTC) drugs (with the exception of hormonal contraception, menopausal hormone replacement therapy or occasional analgesics such as Paracetamol \\[1 g per dose and maximum 2-4 g per day\\], Ibuprofen and standard daily vitamins etc. in short term at the Investigator's discretion), within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;\n7. Participated in any other investigational trials or has been exposed to other investigational drugs within 28 days or 5 half-lives of the previously administered investigational drug, whichever is longer, prior to the first dose of IMPs;\n8. Smoking ≥ 5 cigarettes per day (or an equivalent amount of any other nicotine-containing products) within 6 months before screening or unable to stop smoking during the study;\n9. Alcohol consumption of \\> 21 units per week for males and \\> 14 units per week for females within the 6 months before screening (1 unit=360 mL of beer or 45 mL of spirits with an alcohol content of ≥ 40% or 150 mL of wine) or a positive result of alcohol breath test on admission or unable to abstain from consuming alcohol from 24 h prior to admission, until completion of the end of study (EOS) visit;\n10. History of drug abuse within the 12 months before screening or a positive result of drug abuse test at screening;\n11. Consumption of any nutrients known to modulate cytochrome P450 enzymes or P-gp substrates activity (eg, grapefruit, pomelo, mango, star fruit, Seville \\[blood\\] orange products, caffeine or xanthine-containing food or beverages) within 72 h before the first dose of IMPs;\n12. Clinically significant laboratory abnormalities, as determined by the Investigator, including but not limited to (If the results are beyond the normal range or significantly changed, the investigator deems it necessary to repeat the measurement, vital signs and 12-Lead ECG may be repeated twice, clinical laboratory tests \\[hematology, urinalysis, biochemistry and coagulation function test\\] may be repeated once):\n\n    * Systolic blood pressure (SBP) ≥ 140 mmHg and\u002For diastolic blood pressure (DBP) ≥ 90 mmHg after 5 minutes of supine rest;\n    * Supine resting bradycardia (pulse heart rate \\[HR\\] \\\u003C40 bpm) or a supine resting tachycardia (HR \\>100 bpm);\n    * A corrected QT (QTc) interval of \\> 450 ms for males and \\> 470 ms for females (Fridericia's method);\n    * Liver function: aspartate aminotransferase \\[AST\\], alanine transaminase \\[ALT\\], alkaline phosphatase \\[ALP\\], γ-glutamyl transferase \\[γ- GGT\\]) or total bilirubin (TBIL) \\>1.5 × upper limit of normal (ULN);\n    * Renal function: creatinine clearance rate ≤80 mL\u002Fmin (calculated based on Cockcroft-Gault formula);\n    * Other laboratory parameters demonstrating clinically significant abnormalities, as determined by the investigator;\n13. Known active infections, e.g., bacterial, fungal and viral infections, including:\n\n    * Human immunodeficiency virus (HIV) infection: defined as HIV antibody positive;\n    * Syphilis infection: defined as treponema pallidum antibody (TP-Ab) positive;\n    * Active hepatitis B virus (HBV): defined as hepatitis B surface antigen (HBsAg) positive, Hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) ≥ lab-specific ULN (for those with positive result on HBcAb or HBsAg, HBV DNA test will be performed and those with positive HBV DNA results will be excluded);\n    * Active hepatitis C virus (HCV): defined as HCV antibody (HCV-Ab) positive and HCV-ribonucleic acid (RNA) positive, if HCV-Ab positive and HCV RNA negative can be considered as eligible at the discretion of the Investigator;\n14. Has donated blood or plasma within 30 days prior to screening or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening;\n15. The subject has difficulty in swallowing oral medications;\n16. Inability to be venipunctured and\u002For tolerate venous access; Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the investigator.",true,"45 Years",{"count":60,"type":21},86,[62],"PHASE1","This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are:\n\n1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects.\n2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects.\n\nApproximately 86 subjects will be enrolled in the study.",[65],"Healthy Volunteers","2024-07-25",{"date":68,"type":41},"2024-07-26",{"date":70,"type":41},"2023-10-20",{"date":72,"type":21},"2024-12",{"name":47,"class":48},""]