[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Simcere Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,89,111],{"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":4},"100632195","phase-1-a-crossover-study-to-evaluate-the-relative-bioavailability-of-two-formulations-of-deuterated-remdesivir-hydrobromide-for-oral-suspension-in-healthy-chinese-adults-100632195",false,"NCT07510529","A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults","A Single-Center, Open-Label, Randomized, Two-Sequence, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adult Participants","Inclusion Criteria:\n\n1. Able to read, understand, voluntarily participate, and sign the informed consent form.\n2. Aged 18 to 50 years (inclusive) at screening, male or female.\n3. Body weight ≥50 kg for males and ≥45 kg for females, Body Mass Index (BMI) between 18 and 28 kg\u002Fm\\^2\\^ (inclusive) \\[BMI = weight (kg) \u002F height\\^2\\^ (m\\^2\\^)\\].\n4. Vital signs, physical examination, laboratory tests, ECG, and chest X-ray (posteroanterior view) are normal or judged as abnormal without clinical significance by the investigator.\n5. Participants (including male participants) and their spouses\u002Fpartners must have no pregnancy plan (including sperm\u002Fegg donation) from signing the informed consent form until at least 30 days after the last dose, and voluntarily agree to use effective contraceptive methods.\n6. Able to communicate well with clinical staff and complete the study per protocol requirements.\n\nExclusion Criteria:\n\n1. Presence of clinically significant diseases within 12 months before screening, including but not limited to digestive, circulatory, respiratory, endocrine, urinary, immune, nervous system disorders, and mental\u002Fpsychological diseases.\n2. History of any condition with bleeding risk, such as acute gastritis or gastric\u002Fduodenal ulcer.\n3. Current history of oral ulcers, or acute or chronic infection within 1 week before screening.\n4. Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.\n5. Blood donation or significant blood loss (\\>400 mL) within 3 months before screening.\n6. Allergic constitution (allergic to multiple foods\u002Fdrugs), or known allergy to the investigational product, its components, or related products.\n7. Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, HIV antigen\u002Fantibody, or Treponema pallidum antibody (TP-Ab).\n8. Positive pregnancy test at screening or baseline, or currently breastfeeding.\n9. Screening 12-lead ECG showing QTcF ≥470 ms for males or QTcF ≥480 ms for females. QTcF = QT\u002F\\[(60\u002FHR)\\^0.33\\], where HR is heart rate.\n10. Use of prescription or non-prescription drugs (including traditional Chinese medicine and health supplements) within 14 days or 5 half-lives (whichever is longer) before screening.\n11. Vaccination with live, attenuated live, or any live virus component vaccines within 12 weeks before dosing, or planned during the study period and up to 8 weeks after the last dose.\n12. Participation in any clinical trial and receiving at least one dose of investigational product within 3 months or 5 half-lives (whichever is longer) before screening.\n13. Average weekly alcohol consumption exceeding 14 units within 3 months before screening (1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine).\n14. Average daily smoking \\>5 cigarettes or equivalent tobacco within 3 months before screening.\n15. History of drug abuse within 1 year before screening.\n16. Positive alcohol breath test or positive urine drug abuse screen at baseline.\n17. Unable to tolerate intravenous catheter blood collection or has a needle\u002Fblood phobia.\n18. Consumption of specific diets (including dragon fruit, mango, grapefruit, and\u002For xanthine-containing diet, caffeinated foods or beverages), or strenuous exercise, or consumption of any alcoholic products within 48 hours before dosing.\n19. Unable to comply with standardized meals (e.g., special dietary requirements, refusal to accept standard meals).\n20. Occurrence of acute illness with clinical significance or use of any medication between screening and baseline.\n21. Any other condition that, in the investigator's opinion, may affect the participant's ability to provide informed consent or comply with the protocol, or makes the participant unsuitable for the study, or participation may affect the study results or the participant's safety.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A single-center, open-label, randomized, two-sequence, two-period crossover study in 48 healthy subjects to compare the relative bioavailability of two formulations. The test (T, 0.2 g\u002Fsachet) and reference (R, 0.1 g\u002Fsachet) are administered at a dose of 0.2 g per period: sequence T-R receives 1 sachet T (period 1) and 2 sachets R (period 2); sequence R-T receives 2 sachets R (period 1) and 1 sachet T (period 2). Subjects are randomized 1:1 to either sequence.",[28],"Healthy Participants","NOT_YET_RECRUITING","2026-04-01",{"date":32,"type":33},"2026-04-03","ACTUAL",{"date":35,"type":22},"2026-04-20",{"date":37,"type":22},"2026-06-30",{"name":39,"class":40},"Simcere Pharmaceutical Co., Ltd","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"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":66},"100623890","phase-3-a-phase-iii-study-of-deuremidevir-hydrobromide-for-the-treatment-of-rsv-infection-in-infants-and-young-children-100623890","NCT07402512","A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children","A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection","Inclusion Criteria:\n\n1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;\n2. Weight ≥ 2.5 kg and ≤ 20 kg;\n3. Positive RSV antigen or nucleic acid test\n4. Duration of illness due to RSV infection ≤ 96 hours;\n5. Presence of tachypnea and wheezing;\n6. Wang Bronchiolitis Score≥ 5;\n7. For subjects aged \\\u003C 12 months, head circumference should be within the normal range corresponding to their age and gender.\n\nExclusion Criteria:\n\n1. Subjects who have received protocol-specified prohibited medications:\n2. Subjects with severe intrapulmonary complications or extrapulmonary complications;\n3. Subjects requiring vasopressors or inotropic agents;\n4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;\n5. Subjects with a known history of hypercapnia;\n6. Subjects with chronic or persistent feeding difficulties;\n7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;\n8. Subjects with congenital metabolic abnormalities;\n9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;\n10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;\n11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;\n12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;\n13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;\n14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;\n15. Subjects with a history of epilepsy or febrile convulsions;\n16. Subjects with a personal or family history of severe allergies or allergies;\n17. Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;\n18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;\n19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.","1 Month","36 Months",{"count":51,"type":22},498,[53],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection.\n\nA total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg\u002Fkg three times daily for 5 consecutive days (15 doses).",[56],"Respiratory Syncytial Virus Infection","RECRUITING","2026-03-29",{"date":60,"type":33},"2026-04-02",{"date":62,"type":33},"2026-03-11",{"date":64,"type":22},"2027-06-30",{"name":39,"class":40},4,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100553643","phase-3-sim0718-treatment-of-asthma-clinical-study-100553643","NCT06488755","SIM0718 Treatment of Asthma Clinical Study","A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SIM0718 in Adults and Adolescents With Asthma","Inclusion Criteria:\n\n* Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；\n* Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；\n* Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；\n* Positive bronchodilator response within 12 months prior to randomization or during the screening period;\n* Asthma Control Questionnaire (ACQ-5) score ≥ 1.5;\n* At least one severe asthma exacerbation within 12 months prior to the screening visit and no occurrence within 28 days prior to randomization;\n* Based on the investigator judgment, the subject demonstrates acceptable inhaler, peak flow meter, and spirometry techniques;\n* Compliance with usual asthma controller use ≥ 80% based on the patient diary in 7 days prior to dosing;\n* Voluntarily participate in this clinical study and sign the informed consent form and be able to comply with the clinical visit schedule and study-related procedures;\n* Female subjects of childbearing potential who are sexually active with non-sterilized male partners, male subjects, and their female partners of childbearing potential agree to use adequate and effective contraception throughout the study;\n\nExclusion Criteria:\n\n* Current respiratory disease that may impair lung function as judged by the investigator;\n* Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;\n* Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;\n* Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;\n* History of active tuberculosis; or untreated latent tuberculosis or tuberculosis not receiving standard treatment, unless the investigator judges that the patient has been adequately treated;\n* People with hepatitis B, hepatitis C, or HIV infection;\n* History of malignancy;\n* Major surgery within 8 weeks prior to signing the informed;\n* Bronchial thermoplasty within 12 months prior to randomization;\n* Treatment of systemic glucocorticoid during 4 weeks prior to signing informed to randomization;\n* Previous use or ongoing use of systemic immunosuppressants or biologics for the treatment of autoimmune or inflammatory diseases in 8 weeks or 5 half-lives prior to randomization;\n* Within 16 weeks or 5 half-lives prior to randomization, received a biologic agent with the same therapeutic purpose;\n* Participated in an interventional clinical trial of any drug or medical device within 3 months or 5 half-lives prior to randomization;\n* Poor response to or intolerance to prior anti-IL-4Rα antibody therapy;\n* Within 3 months prior to randomization, received specific immunotherapy；\n* Receipt of intravenous human immunoglobulin (IVIG) or blood products within 30 days prior to randomization;\n* Vaccination with live(attenuated) vaccine within 30 days prior to randomization or plan to receive live (attenuated) vaccine during the study;\n* Are using concomitant medications or treatments that are prohibited in the protocol;\n* The following laboratory abnormalities occurred during the screening period: eosinophils≥1500 cells\u002Fmm3 or 1.5×109\u002FL; Platelets≤80,000 cells\u002Fmm3 or 80×109\u002FL; phosphocreatine kinase (CPK) ≥5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≥3-fold ULN; aspartate aminotransferase (AST)≥ 3-fold ULN; Bilirubin ≥ 2x ULN;\n* History of alcohol abuse or drug abuse within 12 months prior to randomization;\n* Current smokers, or those who have been smoking in recent 6 months, or former smokers who have not been smoking for 6 months with a smoking history of ≥10 pack years;\n* Allergy to L-histidine, trehalose, or Tween 80, or history of systemic hypersensitivity to any biologic products;\n* Females of childbearing potential have a positive pregnancy test result during the screening period; Females planning to become pregnant or breastfeeding;\n* Any clinically significant examination abnormality or serious and\u002For uncontrolled disease that, in the opinion of the investigator, may affect the subject safety, or affect the evaluation of efficacy, or preclude the subject completion of the entire study.","12 Years","75 Years",{"count":77,"type":22},418,[53],"Phase III clinical study of SIM0718 asthma",[81],"Asthma; Eosinophilic",{"date":60,"type":33},{"date":84,"type":33},"2024-06-23",{"date":86,"type":22},"2027-09-30",{"name":39,"class":40},1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":88},"100623193","phase-2-a-multicenter-phase-2a-clinical-study-to-evaluate-sim0278-in-subjects-with-active-lupus-nephritis-100623193","NCT07393451","A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis","A Randomized, Double-blind, Placebo, Parallel-Controlled, Multicenter Phase 2a Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SIM0278 in Subjects With Active Lupus Nephritis","Inclusion Criteria:\n\n1. Weight ≥ 40.0 kg\n2. SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria.\n3. Subjects must be receiving or willing to initiate induction therapy for LN. Induction therapy, defined as including high-dose glucocorticoids and MMF, should be initiated within 60 days or on the same day prior to baseline.\n\nExclusion Criteria:\n\n1. Previous or current nephropathy (except LN) that, in the opinion of the investigator, may interfere with the LN assessment and interfere with the assessment of disease activity (e.g., diabetic nephropathy). The subject was unable or unwilling to provide written informed consent and\u002For to comply with study procedures.\n2. Severe renal impairment: a) oliguria (defined as recorded urine volume \\\u003C 400 mL\u002F24 h), or b) end-stage renal disease (ESRD) requiring dialysis or transplantation.\n3. Previous induction therapy for MMF\u002FMPS was considered by the investigator to have failed.",{"count":97,"type":22},60,[99],"PHASE2","This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy.\n\nApproximately 60 subjects with active LN are planned to be enrolled and randomized 1: 1 to SIM0278 or placebo.\n\nThe study consists of 3 phases: screening, double-blind treatment, and safety follow-up.",[102],"Lupus Nephritis","2026-01-30",{"date":105,"type":33},"2026-02-06",{"date":107,"type":22},"2026-03-31",{"date":109,"type":22},"2028-08-31",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100540314","phase-2-edaravone-dexborneol-sublingual-tablet-for-the-psci-in-acute-ischemic-stroke-patients-100540314","NCT06315231","Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients","Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.","Inclusion Criteria:\n\n1. Age ≥ 40 years and ≤ 80 years, male or female.\n2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).\n3. The National Institutes of Stroke Scale score ≤ 20 points.\n4. Time from onset to obtained informed consent form is within 7 days (including 7 days).\n5. Presence of cognitive dysfunction at screening, i.e., MoCA scale score \\\u003C 22.\n6. Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.\n7. Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.\n8. female subjects of childbearing potential and male subjects whose female partners are of childbearing potential must be willing to and use contraception during the study treatment and within 30 days after the last dose of study drug and have no plans to donate sperm or eggs; female subjects of childbearing potential will have a negative pregnancy test;\n9. obtain voluntary signed informed consent from the patient or his\u002Fher legal representative approved by the Ethics Committee.\n\nExclusion Criteria:\n\n1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.\n2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \\> 1 point.\n3. Transient ischemic attack (TIA).\n4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.\n5. Poorly controlled diabetes (fasting blood glucose \\>10mmol\u002FL and\u002For HbA1c\\>8%).\n6. Patients with contraindications to MRI imaging.\n7. For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.\n8. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.\n9. Patients who have been diagnosed with severe mental disorders prior to stroke.\n10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.\n11. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo Biloba Tablets, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ).\n12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST \\> 2.0 × ULN.\n13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \\> 1.5 × ULN.\n14. Thrombectomy or interventional therapy has been applied or planned after this episode.\n15. History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. Subjects with a diagnosis of malignancy after enrollment may continue to participate in the study or not at the discretion of the investigator and at the discretion of the subject;\n16. Suffering from a severe systemic disease with an expected survival period of \\\u003C1 year;\n17. hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);\n18. pregnancy, lactation, and patients planning pregnancy;\n19. history of major surgery within 4 weeks prior to enrollment;\n20. participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;\n21. in the opinion of the investigator, not suitable for participation in this clinical study.","40 Years","80 Years",{"count":121,"type":22},226,[99],"This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.\n\nThe goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.\n\nParticipants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.",[125],"Post-stroke Cognitive Impairment","2025-09-01",{"date":128,"type":33},"2025-09-03",{"date":130,"type":33},"2024-04-08",{"date":132,"type":22},"2026-12-30",{"name":39,"class":40},21,""]