[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"InnovStone Therapeutics Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100642166","phase-1-a-single-and-multiple-ascending-dose-study-to-evaluate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-syh2072-tablets-100642166",false,"NCT07647783","A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2072 Tablets","A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2072 Tablets in Healthy Participants","Inclusion Criteria:\n\n1. Participants must be fully informed about the study content, procedures, and potential adverse reactions, and voluntarily sign the written informed consent form (ICF) before the study;\n2. Sex: Male or female;\n3. Age: 18-55 years old (inclusive);\n4. Body mass index in the range of 19 to 30 kg•m-2 \\[Body Mass Index (BMI) = weight\u002Fheight2 (kg•m\\^2)\\] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);\n5. Participants are able to communicate well with the investigator and are able to complete the study in accordance with the protocol.\n\nExclusion Criteria:\n\n1. History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);\n2. Use of corticosteroid drugs within 3 months prior to screening;\n3. Past and\u002For current clinically significant medical conditions, including but not limited to diseases of the circulatory, hematologic or hematopoietic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, tumors, severe trauma, or any other disease that the investigator considers should be excluded or may interfere with the interpretation of the study results;\n4. Postural tachycardia (heart rate increase \\> 30 beats\u002Fminute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;\n5. Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;\n6. Potassium ion level outside the normal range in clinical chemistry tests at screening, or serum creatinine \\> upper limit of normal (ULN);\n7. Any one of the following at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) \\> 1.2×ULN (one re-test within 1 week is allowed);\n8. Estimated glomerular filtration rate (eGFR) \\\u003C 90mL\u002Fmin\u002F1.73 m2 at screening;\n9. Prolonged QT\u002FQTc interval at screening (QTcF ≥ 450ms for males, ≥ 470ms for females);\n10. Positive for any of the following: HBsAg, HCV antibody, syphilis antibody, or HIV antibody;\n11. Blood loss or blood donation exceeding 200mL within 3 months prior to screening (excluding menstruation for females), and\u002For platelet donation within 2 weeks;\n12. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or dietary supplements (including vitamins, health products, etc.) within 28 days prior to screening;\n13. History of drug abuse, and\u002For use of illicit drugs within 3 months prior to screening, and\u002For habitual use of any psychotropic drugs, including Chinese herbal medicines, and\u002For a positive urine drug screen;\n14. Average daily smoking of more than 5 cigarettes (or an equivalent amount of tobacco in e-cigarettes) within 3 months prior to screening, and\u002For unwilling to avoid using any tobacco products during the study;\n15. Regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360mL of 5% alcohol beer or 45mL of 40% alcohol spirits or 150mL of 12% alcohol wine), and\u002For inability to abstain from alcohol intake during the study, and\u002For a positive breath alcohol test;\n16. Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages (8 cups or more, 1 cup = 250mL) within 1 month prior to screening, and\u002For unwilling to abstain from tea, coffee, and\u002For caffeinated foods, grapefruit and\u002For grapefruit juice, and\u002For poppy-containing products during the study;\n17. Having a fertility plan (including sperm or egg donation) from the time of signing the ICF until 3 months after the last dose, and\u002For unwilling to use an effective non-drug method of contraception;\n18. Participation in any clinical study within 3 months prior to screening;\n19. Participants who may be unable to complete the study for other reasons or who are deemed unsuitable for inclusion by the investigator.\n\n    In addition to the above requirements, female participants who meet the following criteria will also be excluded:\n20. Pregnant or lactating women;\n21. Use of oral contraceptives within 28 days prior to screening;\n22. Use of long-acting estrogen and\u002For progestogen injections and\u002For implants within 6 months prior to screening; 23）Women of childbearing potential who have had unprotected sexual intercourse with a partner within 28 days prior to dosing.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},112,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants.",[28],"Healthy Participants","RECRUITING","2026-06-09",{"date":32,"type":33},"2026-06-15","ACTUAL",{"date":35,"type":33},"2026-01-15",{"date":37,"type":22},"2027-04-01",{"name":39,"class":40},"InnovStone Therapeutics Limited","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100637831","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-syh2059-tablets-in-adult-patients-with-idiopathic-pulmonary-fibrosis-100637831","NCT07600021","A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis.","Inclusion Criteria:\n\n* 1\\. Age ≥ 40 years, regardless of gender;\n* 2\\. The investigator confirms the clinical diagnosis of IPF in participants based on chest HRCT, surgical lung biopsy, or transbronchial lung cryobiopsy (if available) performed during the screening period or within 1 year prior to screening (see Appendix 13.7 for details);\n* 3\\. FVCpp ≥ 45% during the screening period;\n* 4\\. Hemoglobin-corrected DLCOpp ≥ 25% and \\\u003C 90% during the screening period;\n* 5\\. Received a single stable-dose antifibrotic therapy for at least 12 weeks prior to screening (concurrent use of nintedanib and pirfenidone is prohibited) and will continue after randomization; or had not received stable antifibrotic therapy, or had discontinued such therapy for at least 8 weeks, with no plan to initiate antifibrotic therapy during the trial;\n* 6\\. Understands the purpose and risks of this study, comprehends and agrees to comply with all study procedures, consents to participate, and provides written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Interstitial lung disease other than IPF.\n* 2\\. Airway obstruction during screening (FEV₁\u002FFVC \\\u003C 0.7), or emphysema greater than pulmonary fibrosis on HRCT.\n* 3\\. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening.\n* 4\\. Investigator judgment that IPF severity showed sustained improvement during the 12 months prior to screening, based on changes in FVC, DLCO and\u002For HRCT findings.\n* 5\\. Other clinically significant respiratory diseases during screening.\n* 6\\. Severe diseases in any other system (cardiovascular, digestive, neurological, hematological, endocrine) during screening.\n* 7\\. Malignancy within 5 years prior to screening (excluding treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).\n* 8\\. Any acute infection within 2 weeks prior to screening that has not fully recovered per investigator judgment.\n* 9\\. Active, unstable or uncontrolled vasculitis within 8 weeks prior to screening.\n* 10\\. Any acute or chronic active infection during screening.\n* 11\\. C-SSRS assessment during screening indicating suicidal behavior within the past 2 years (actual attempt, interrupted attempt, aborted attempt, or preparatory acts or gestures), or clinically significant suicidal ideation within 3 months prior to screening or during screening (participant answered \"yes\" to C-SSRS suicidal ideation question 4 or 5).\n* 12\\. Treatment with PDE1, PDE3, PDE4, PDE10 inhibitors, or non-selective PDE inhibitors within 4 weeks prior to screening.\n* 13\\. Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of investigational product, or inability to discontinue such agents during the study.\n* 14\\. Receiving immunomodulatory agents (excluding oral glucocorticoids) for respiratory or pulmonary conditions during screening, or prednisone (or equivalent) at a daily dose \\> 15 mg.\n* 15\\. Abnormal hepatic and renal function during screening: ALT, AST \\> 2.5 × ULN, or TBIL \\> 1.5 × ULN, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* 16\\. Severe, persistent, uncontrolled hypertension during screening (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg).\n* 17\\. History of smoking within 3 months prior to screening or unwillingness to abstain from smoking (including e-cigarettes) during the study.\n* 18\\. Hypersensitivity to SYH2059 or any excipients, or history of severe drug allergy.\n* 19\\. Participation in any clinical trial within 4 weeks prior to screening (excluding those not receiving investigational product).\n* 20\\. Participation in a clinical study of the same target drug and receipt of treatment within 3 months prior to screening.\n* 21\\. Pregnant or lactating females; fertile females or males unwilling to practice strict contraception throughout the trial and for 3 months after trial completion until the end of the safety follow-up period (including male participants).\n\nAny other conditions deemed inappropriate for trial participation by the investigator.\n\n* 22\\. Additional Exclusion Criteria (for PK intensive sampling participants):\n* 23\\. Previous history of gastrointestinal surgery that may interfere with the PK of the investigational product.\n* 24\\. Alcohol consumption exceeding 14 units per week within 4 weeks prior to screening.\n* 25\\. Habitual excessive intake of xanthine- or caffeine-containing foods, beverages, or other substances affecting drug absorption, distribution, metabolism or excretion within 4 weeks prior to screening.","40 Years",{"count":51,"type":22},156,[53],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.",[56],"Idiopathic Pulmonary Fibrosis","NOT_YET_RECRUITING","2026-05-14",{"date":60,"type":33},"2026-05-20",{"date":62,"type":22},"2026-06-30",{"date":64,"type":22},"2027-12-30",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100632228","phase-1-a-single--and-multiple--ascending-dose-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-syh2059-powder-for-inhalation-100632228","NCT07510958","A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation","A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation in Healthy Participants","Inclusion Criteria:\n\n* 1\\) Adults aged 18 \\~ 55 years (inclusive), male or female;\n* 2\\) Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 \\~ 28.0 kg\u002Fm\\^2 (inclusive);\n* 3\\) Participant has not engaged in unprotected sexual intercourse within 14 days before screening, and participant and their partner agree to use effective non-hormonal contraception (such as condoms, inert intrauterine devices, female barrier method (cervical cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.) from signing the ICF to 6 months after the end of the study; No sperm donation plan for male participants from signing the ICF to 6 months after the end of the study, and no egg donation plan for female participants from signing the ICF to 6 months after the end of the study;\n* 4\\) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written ICF and can comply with the trial procedures.\n\nExclusion Criteria:\n\n* 1\\) History of neurological\u002Fpsychiatric system, respiratory, endocrine, hematological, musculoskeletal, gastrointestinal, and cardiovascular diseases; hepatic and renal diseases, thymic disorders or other diseases that may affect the study results;\n* 2\\) History of severe drug and food allergies, including allergy to the product or its components; history of herpes zoster infection;\n* 3\\) Pulmonary ventilation function test showing FEV1 measured value\u002Fpredicted FEV1 ≤ 80% or FVC ≤ 80% of predicted value, or clinically significant;\n* 4\\) History of COPD or other respiratory diseases, such as active or inactive tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, overt asthma, positive bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease;\n* 5\\) Individuals currently suffering from oral lesions or oral ulcers;\n* 6\\) Individuals engaged in high-risk occupations or fine work (such as high-altitude workers, pilots, etc.);\n* 7\\) Participants who have taken any prescription drugs, over-the-counter drugs, Chinese patent medicines, herbal medicines, vitamin dietary supplements, or health products (especially CYP enzyme or transporter inhibitors or inducers) within 4 weeks before randomization; or participants using oral long-acting contraceptives or embedded long-acting contraceptives;\n* 8\\) Participants with diseases affecting drug absorption, distribution, metabolism and excretion (such as acute and chronic diarrhea, acute and chronic gastritis, gastrectomy, cholecystectomy, intestinal resection, etc., except appendectomy) as judged by the investigator;\n* 9\\) Participants who cannot receive oral activated charcoal or are allergic to activated charcoal (only 4 mg dose group, tentative);\n* 10\\) Participants with irregular defecation（only 4 mg dose group, tentative）;\n* 11\\) Participants who have undergone any surgical operation within 6 months before signing the ICF;\n* 12\\) Participants with a history of systemic acute infection within 2 weeks before signing the ICF;\n* 13\\) Participants who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial, or those who plan to participate in strenuous exercise (including body contact sports or collision sports) during the trial;\n* 14\\) Participants who have received any live vaccine (except influenza vaccine) within 28 days prior to screening or plan to receive vaccination during the study;\n* 15\\) Participants who have received any investigational drug or participated in any drug clinical trial within 3 months prior to screening, or participated in other medical research activities, and are judged by the investigator to experience discomfort unsuitable for participation in this study;\n* 16\\) Participants whose physical examination, vital signs measurement, laboratory tests (hematology, urinalysis, stool routine, blood biochemistry, coagulation function, etc.), Chest X-ray (PA \\& LAT) and abdominal B-ultrasound examination during the screening are judged by the study doctor to be abnormal and clinically significant ;\n* 17\\) Participants with clinically significant ECG abnormalities, QTcF interval ≥ 450 ms (male) or ≥ 470 ms (female), complete left bundle branch block, ST-T interval changes indicating myocardial ischemia, second- or third-degree conduction block, severe bradyarrhythmia or tachyarrhythmia, or history of prolonged QTcF interval;\n* 18\\) Participants who have experienced blood loss or blood donation exceeding 400 mL, received transfusions or use of blood products within 3 months prior to signing the ICF;\n* 19\\) Participants with special dietary requirements who cannot adhere to the standard study diet;\n* 20\\) Subjects with a history of needle syncope, motion sickness or those who cannot tolerate intravenous paracentesis for blood collection;\n* 21\\) Alcoholics: regular drinkers (more than 14 units per week for women and more than 21 units per week for men, such as 360mL beer or 45mL 40% spirits or 150mL wine) in the 6 months prior to signing the ICF, or unable to abstain from alcohol during the study, or a positive alcohol breath test (\\> 0 mg\u002F100 mL);\n* 22\\) Smokers: smoking ≥5 cigarettes per day for 6 months before signing the ICF or a positive smoke test result;\n* 23\\) Habitual intake of excessive xanthine or caffeine-containing foods or beverages, or other foods affecting drug absorption, distribution, metabolism, excretion and other factors within 1 month prior to screening. For example, coffee (more than 1100mL per day), tea (more than 2200 mL per day), cola (more than 2200 mL per day), energy drinks (more than 1100 mL per day), chocolate (more than 510 g per day);\n* 24\\) Participants with a history of drug abuse\u002Fdrug use, or those who test positive in drug abuse screening (including benzodiazepine, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinolic acid);\n* 25\\) Pregnant or breastfeeding women, or those with positive blood pregnancy test result during screening period;\n* 26\\) Participants with hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV), syphilis-specific antibody (TPPA) and human immunodeficiency virus antigen antibody (Anti-HIV) positive during the screening period;\n* 27\\) Participants unwilling or unable to correctly use the inhaler to inhale the investigational product according to the inhaler instructions or those who fail in inhaler training;\n* 28\\) Participants with other factors that, in the opinion of the investigator, are not suitable for participation in the clinical trial.",{"count":74,"type":22},84,[25],"Randomized, double-blind and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of SYH2059 powder for inhalation after single and multiple doses in healthy subjects. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2059 powder for inhalation. Part 2 is to assess the safety, tolerability and pharmacokinetics of a multiple ascending dose of SYH2059 powder for inhalation.",[28],"2026-03-29",{"date":80,"type":33},"2026-04-06",{"date":82,"type":22},"2026-03-15",{"date":84,"type":22},"2027-02-28",{"name":39,"class":40},""]