[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Chia-tai Tianqing Pharmaceutical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":245},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,63,85,102,123,147,164,187,204,224],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100628476","phase-1-an-efficacy-and-safety-study-of-ntb003-in-participants-with-thyroid-eye-disease-ted-100628476",false,"NCT07462130","An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)","A Phase Ib\u002FII, Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* 1\\. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs\u002Fsymptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS \\\u003C 3, and the first onset of TED ocular signs\u002Fsymptoms (by subject report or medical records) occurred \\> 12 months prior to first study drug administration.\n\n  4.Subjects clinically graded as having moderate-to-severe TED per the European Group on Graves' Orbitopathy (EUGOGO) classification at screening and baseline, typically accompanied by proptosis ≥ 3 mm above the upper limit of normal (normal range 12-16 mm). In addition, subjects should have one or more of the following features: eyelid retraction ≥ 2 mm, moderate or severe soft-tissue involvement, or intermittent\u002Fpersistent diplopia.\n\n  5.Do not require immediate ophthalmic surgical intervention and no corrective surgery or orbital radiotherapy is planned during the study.\n\n  6.Euthyroid with underlying thyroid disease controlled, or mild hypothyroidism or hyperthyroidism (defined as screening free triiodothyronine \\[FT3\\] and free thyroxine \\[FT4\\] levels \\\u003C 50% above or below the normal limits).\n\n  7.Subjects of childbearing potential must agree to use effective contraception during the trial and for at least 6 months after the last dose. Acceptable methods include complete abstinence, barrier contraception (e.g., condom), tubal ligation, intrauterine device, hormonal contraception (oral contraceptives, injections, transdermal patch, vaginal ring, or implant), or partner vasectomy.\n\n  8.Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration and must not be breastfeeding.\n\nExclusion Criteria:\n\n* 1\\. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.\n\n  2.Within 6 months prior to screening, decrease in best corrected visual acuity (BCVA) attributable to TED optic neuropathy, defined as a loss of two lines of acuity, new visual field defect, or color vision defect secondary to optic nerve involvement.\n\n  3.Corneal abnormalities that, in the investigator's opinion, could affect efficacy assessments.\n\n  4.Prior or planned orbital radiotherapy or ocular surgery for TED, including orbital decompression, strabismus surgery, eyelid surgery, or similar procedures.\n\n  5.History of clinically significant hearing impairment, or abnormal pure-tone audiometry at screening.\n\n  6.History of inflammatory bowel disease, or clinically suspected inflammatory bowel disease (e.g., unexplained diarrhea with or without blood or rectal bleeding plus abdominal pain or cramping for \\>4 weeks; endoscopic or imaging evidence of enteritis\u002Fcolitis without other explanation).\n\n  7.Prior treatment with IGF-1 or IGF-1R-related agents. 8.Poorly controlled diabetes at screening. 9.Poorly controlled hypertension at screening. 10.AST or ALT \\> 3×ULN; or serum creatinine \\> 1.5×ULN; or platelet count \\\u003C 100 × 10\\^9\u002FL; or neutrophil count \\\u003C 2.0 × 10\\^9\u002FL at screening:.\n\n  11.Active hepatitis, defined as HBsAg positive with detectable HBV DNA above the local laboratory's lower limit of detection; or HCV antibody positive.\n\n  12.History of HIV infection or positive HIV antibody test. 13.Any active or suspected bacterial, viral, or fungal infection (e.g., severe common cold, viral syndrome, influenza-like illness) requiring intravenous antimicrobial therapy within 4 weeks prior to first dose.\n\n  14.Receipt of, or planned receipt during the study of, live or live-attenuated vaccines within 4 weeks prior to first dose.\n\n  15.Use of selenium, biotin, or traditional Chinese medicine therapies for TED (e.g., triptolide-containing compounds, Epimedium, polygonum cuspidatum, lotus seed heart, acupuncture, etc.) within 3 weeks prior to first dose or planned use during the study; combination multivitamins containing selenium and\u002For vitamins are permitted.\n\n  16.Use of oral or intravenous systemic glucocorticoids for any reason within 4 weeks prior to first dose; or topical ophthalmic glucocorticoid eye drops\u002Fointments for TED within 7 days prior to first dose. Use of topical glucocorticoids for non-TED indications (e.g., dermatologic conditions) before or during the study is allowed.\n\n  17.Use of oral or intravenous nonsteroidal immunosuppressants for TED (e.g., mycophenolate mofetil, cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks prior to first dose; or topical ophthalmic nonsteroidal immunosuppressant eye drops for TED within 7 days prior to first dose.\n\n  18.Periocular\u002Forbital steroid injection within 3 months prior to first dose. 19.Treatment with anti-CD20 antibodies, interleukin-6 antibodies, or other biologic agents for TED within 3 months prior to first dose.\n\n  20.Botulinum toxin (or other chemical denervation agents) treatment for TED within 3 months prior to first dose.\n\n  21.Participation in another interventional clinical trial within 3 months prior to first dose.\n\n  22.Known or suspected allergy to the investigational product or any of its components, or prior history of hypersensitivity to other antibody drugs.\n\n  23.Any prior or concomitant disease or condition that, in the investigator's judgment, may interfere with trial compliance or affect evaluation of trial results (e.g., psychiatric disorders, recent acute cardiovascular or cerebrovascular events, history of treated or untreated malignancy within 5 years), or any other condition deemed by the investigator to make the subject unsuitable for participation.","ALL","18 Years","75 Years",{"count":20,"type":21},74,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Multicentre, Phase Ib\u002FII Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease",[28],"Thyroid Eye Disease","NOT_YET_RECRUITING","2026-03-09",{"date":32,"type":33},"2026-03-10","ACTUAL",{"date":35,"type":21},"2026-03-01",{"date":37,"type":21},"2028-03-30",{"name":39,"class":40},"Nanjing Chia-tai Tianqing Pharmaceutical","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100623183","phase-3-a-phase-iii-clinical-trial-of-ntq1062-in-combination-with-fulvestrant-for-the-treatment-of-advanced-or-metastatic-hrher2--breast-cancer-100623183","NCT07393321","A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+\u002FHER2- Breast Cancer","A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of NTQ1062 in Combination With Fulvestrant Versus Placebo Plus Fulvestrant in Patients With Locally Advanced (Unresectable) or Metastatic HR+\u002FHER2- Breast Cancer Who Relapsed or Progressed During or After Endocrine Therapy.","Inclusion Criteria:\n\n* (1) Adult female or male subjects who sign the informed consent form and are at least 18 years of age at the time of signing; (2) pre- and\u002For post-menopausal women are eligible for inclusion. Premenopausal women must receive ovarian function suppression treatment during the study, such as gonadotropin-releasing hormone agonists (GnRHa). Menopause is defined as: prior bilateral oophorectomy; age ≥ 60 years; age \\\u003C 60 years, with amenorrhea for ≥ 12 months without prior chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy, and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal reference range; (3) Histologically confirmed HR positive, HER-2-negative recurrent locally advanced or metastatic breast cancer, as determined by testing of a recent tumor sample; (4) Prior treatment with at least one endocrine therapy regimen (monotherapy or combination therapy, including aromatase inhibitors and selective ER modulators); (5) Subjects must have at least one measurable disease lesion assessable by CT or MRI, or at least one osteolytic or mixed (osteolytic + sclerotic) bone lesion at baseline; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (7) No contraindications to fulvestrant, and meets the eligibility requirements for fulvestrant treatment, as assessed by the investigator; (8) Expected survival time of more than 6 months, as assessed by the investigator; (9) Good bone marrow reserve and organ function; (10) Premenopausal women must have a negative pregnancy test before administration and agree to use effective contraception during the trial and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. unsuitable for endocrine anti-tumor therapy by the investigators, such as symptomatic visceral crises or inflammatory breast cancer that may be life-threatening in the short term;\n2. unable to take oral medication, or with severe gastrointestinal disorders that may affect drug absorption, such as intractable nausea and vomiting, chronic diarrhea (diarrhea lasting \\>4 weeks), or intestinal obstruction;\n3. clinically significant glucose metabolism abnormalities, defined as: diagnosed with type 1 diabetes; type 2 diabetes requiring insulin treatment; glycated hemoglobin (HbA1c) ≥8%; fasting blood glucose \\>9.3 mmol\u002FL in patients with history of type 2 diabetes, or fasting blood glucose \\>7.0 mmol\u002FL in patients without history of diabetes;\n4. prior use of fulvestrant or other selective estrogen receptor degraders (SERDs) or any PI3K\u002FmTOR\u002FAkt inhibitors;\n5. other malignancies besides breast cancer within 5 years prior to screening (excluding basal or squamous cell skin cancer, papillary thyroid carcinoma, bladder carcinoma in situ, or cervical carcinoma in situ, or other tumors that have been radically treated and have shown no clinical recurrence for at least 5 years);\n6. have undergone major surgery within 28 days prior to the first dose;\n7. have participated in other interventional clinical studies of unmarketed products within 28 days prior to the first dose;\n8. severe infections requiring systemic intravenous antibiotics within 28 days prior to the first dose;\n9. have received \\>30% bone marrow radiotherapy or extensive radiotherapy within 28 days prior to the first dose, or palliative local radiotherapy (such as thoracic spine and rib radiotherapy) within 14 days prior to the first dose;\n10. have received chemotherapy, endocrine therapy, CDK4\u002F6 inhibitors, traditional Chinese medicine with clear anti-tumor indications, or other small molecule targeted anti-tumor drugs within 14 days prior to the first dose or within 5 half-lives of the drug (whichever is shorter);\n11. Received potent CYP3A inhibitors or potent CYP3A inducers within 14 days before the first dose;\n12. Previous anti-tumor treatment-related toxicities have not recovered to ≤ grade 1 (assessed according to CTCAE 5.0 criteria, excluding indicators required by the inclusion criteria and toxicities judged by the investigator to pose no safety risk, such as alopecia, grade 2 peripheral neuropathy, and hypothyroidism stabilized by hormone replacement therapy);\n13. Known active central nervous system (CNS) metastases, including symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression. Patients who are asymptomatic or stable after treatment and do not require steroid treatment are eligible for enrollment, provided that imaging studies during the screening period confirm no progression for at least 4 weeks;\n14. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease;\n15. History of severe cardiovascular or cerebrovascular disease;\n16. active hepatitis, defined as positive for hepatitis B surface antigen (HBsAg) and HBV DNA titer above the local laboratory's lower limit of detection; or positive for hepatitis C virus (HCV) antibody and HCV RNA above the local laboratory's lower limit of detection;\n17. History of positive human immunodeficiency virus (HIV) test or positive HIV antibody test result;\n18. Clinically uncontrollable pleural, abdominal, or pericardial effusion requiring repeated drainage at the time of screening;\n19. Allergy to any active or inactive ingredient of NTQ1062, fulvestrant, or LHRH agonists;\n20. Presence of pre-existing or concomitant diseases that the investigator believes may interfere with trial compliance;\n21. Pregnant or breastfeeding women.",{"count":49,"type":21},210,[51],"PHASE3","NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with fulvestrant in patients with HR positive, HER2 negative, locally advanced (unresectable) or metastatic breast cancer that has recurred or progressed during or after endocrine therapy and harbors PIK3CA\u002FAKT1\u002FPTEN alterations.",[54],"HR Positive\u002FHER2 Negative Advanced or Metastatic Breast Cancer","2026-01-30",{"date":57,"type":33},"2026-02-06",{"date":59,"type":21},"2026-02-10",{"date":61,"type":21},"2031-08-31",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100606615","phase-3-a-phase-iii-study-of-ntq5082-capsules-in-the-treatment-of-paroxysmal-nocturnal-hemoglobinuria-patients-100606615","NCT07177859","A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients","A Multicenter, Randomized, Open-label, Active-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria","Inclusion Criteria:\n\n\\- 1) Age ≥ 18 years, regardless of gender. 2) Subjects diagnosed with PNH according to the PNH diagnostic criteria in the Chinese \"Guidelines for the Diagnosis and Treatment of Rare Diseases\" (2019 edition), with PNH erythrocyte and\u002For granulocyte clone levels \\> 10% within 6 months prior to screening or during the screening period.\n\n3\\) PNH patients who have not previously received complement inhibitor therapy. 4) Laboratory test (central laboratory) hemoglobin meets one of the following conditions: (1) The average hemoglobin value during screening period V1 and V2 (interval ≥ 7 days) is \\\u003C100g\u002FL; (2) If the subject receives red blood cell transfusion for PNH-related anemia during the screening period, the hemoglobin value at V1 must be \\\u003C100g\u002FL; 5) Blood lactate dehydrogenase (LDH) (central laboratory) is \\>1.5×upper limit of normal (ULN) during screening period V1 and V2 (interval ≥ 7 days);\n\nExclusion Criteria:\n\n* 1\\) During the screening period, laboratory (local laboratory) results show bone marrow failure (reticulocyte count \\\u003C100×109\u002FL, or platelet count \\\u003C30×109\u002FL \\[must not have received platelet transfusion within 7 days prior to the laboratory test\\], or neutrophil count \\\u003C0.5×109\u002FL \\[must not have received short-acting granulocyte colony-stimulating factor within 14 days or long-acting granulocyte colony-stimulating factor within 28 days prior to the laboratory test\\]).\n\n  2\\) During the screening period, laboratory (local laboratory) results show alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma-glutamyltransferase (GGT) \\>3×ULN and the investigator determines that the patient is not suitable for study participation.\n\n  3\\) Patients were receiving any of the following medications before screening, and the duration of treatment at a stable dose of the drug: (1) systemic glucocorticoids for less than 4 weeks; or prednisone or equivalent dose of glucocorticoids at a dose of \\>15 mg\u002Fday; (2) iron, vitamin B12, folic acid, or androgens for less than 4 weeks; (3) vitamin K antagonists (such as warfarin) with a stable international normalized ratio (INR) for less than 4 weeks; (4) low molecular weight heparin, oral anticoagulants (such as aspirin, rivaroxaban, edoxaban, apixaban) for less than 4 weeks; (5) erythropoietin (ESA), hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI), or immunosuppressants (including but not limited to cyclosporine, tacrolimus, mycophenolate mofetil or mycophenolic acid, cyclophosphamide, methotrexate, etc.) for less than 8 weeks.\n\n  4\\) Previous history of bone marrow\u002Fhematopoietic stem cell or solid organ transplantation (such as heart, lung, kidney, liver). 5) Patients with a history of splenectomy or planned surgery during the trial.\n\n  6\\) Patients with a history of recurrent invasive infection with encapsulated bacteria (such as meningococci, Streptococcus pneumoniae, etc.), a history of systemic anti-tuberculosis treatment or current tuberculosis infection, or a history of active systemic bacterial, viral, or fungal infection within 14 days prior to the first administration of the investigational drug (defined as D1) (as determined by the investigator).",{"count":71,"type":21},78,[51],"NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, randomized, open-label, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria.",[75],"Paroxysmal Nocturnal Hemoglobinuria","2025-09-10",{"date":78,"type":33},"2025-09-17",{"date":80,"type":21},"2025-11",{"date":82,"type":21},"2026-11",{"name":39,"class":40},1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":84},"100606616","phase-3-a-long-term-efficacy-and-safety-of-ntq5082-capsules-100606616","NCT07177872","A Long-term Efficacy and Safety of NTQ5082 Capsules","A Multicenter, Open-label Study Evaluating the Long-term Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria","Inclusion Criteria:\n\n* 1\\) Age ≥ 18 years, regardless of gender. 2) Subjects who have previously received and completed NTQ5082 study treatment and, as determined by the investigator, have benefited from treatment and are likely to benefit from continued NTQ5082 treatment, or subjects in the control group receiving eculizumab.\n\n  3\\) Subjects who have received ACYW135 group meningococcal and pneumococcal vaccines as required by the previous protocol, and whose vaccine protection period, as determined by the investigator, falls within the treatment duration of this study.\n\n  4\\) Subjects who agree to use at least one effective contraceptive method during sexual intercourse with their partner from the time they sign the informed consent form until 4 weeks after the last dose, refrain from cryopreservation of sperm or eggs, and refrain from sperm or egg donation.\n\n  5\\) Subjects who agree to sign the informed consent form and commit to abide by all study regulations.\n\nExclusion Criteria:\n\n* 1\\) Previous history of bone marrow\u002Fhematopoietic stem cell or solid organ transplant (e.g., heart, lung, kidney, liver).\n\n  2\\) Previous history of splenectomy. 3) Previous history of recurrent invasive infection with encapsulated bacteria (e.g., meningococci, Streptococcus pneumoniae), previous history of systemic anti-tuberculosis treatment, or current tuberculosis infection.\n\n  4\\) History of malignancy within 5 years prior to screening, excluding cured localized basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or carcinoma in situ of the cervix.\n\n  5\\) Known or suspected hereditary complement deficiency or primary or severe secondary immunodeficiency. 6) Patients with a history of clinically significant kidney, heart, liver, or lung disease who are deemed unsuitable for participation by the investigator, including but not limited to severe kidney disease (e.g., eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²), advanced heart disease (e.g., NYHA class IV), or severe lung disease (e.g., severe pulmonary hypertension (WHO class IV).\n\n  7\\) Patients suspected of being allergic to the study drug or any component of the study drug.\n\n  8\\) Pregnant or lactating female subjects. 9) Other conditions deemed unsuitable for participation by the investigator.",{"count":71,"type":21},[51],"NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, open-label study evaluating the long-term efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria",[75],{"date":78,"type":33},{"date":98,"type":21},"2026-06",{"date":100,"type":21},"2028-06",{"name":39,"class":40},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100591562","phase-2-evaluate-the-efficacy-and-safety-of-ntq5082-capsules-in-patients-with-primary-iga-nephropathy-100591562","NCT06982040","Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Age ≥18 years, male or female.\n2. Body weight ≥40 kg, BMI between 15 to 38 kg\u002Fm².\n3. Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.\n4. 24-hour urine protein excretion (24h-UPE) ≥0.75 g\u002F24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g\u002Fg.\n5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m².\n6. Previously vaccinated with ACYW135 meningococcal polysaccharide vaccine and pneumococcal vaccine.\n7. Received renin-angiotensin system (RAS) inhibitor therapy for at least 12 weeks prior to randomization, with stable treatment at the maximum recommended dose or maximum tolerated dose of RAS inhibitors for at least 4 weeks prior to randomization.\n8. Agreement to use at least one effective contraceptive method with partners during sexual activity from signing the informed consent form until 4 weeks after the last administration of the investigational product, and refrain from sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n1. Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n2. Continuous use of systemic corticosteroids, immunosuppressants\u002Fmodulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n3. Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n4. History of gastrointestinal surgery potentially altering drug absorption\u002Fdistribution\u002Fmetabolism\u002Fexcretion, severe gastrointestinal disorders, or conditions causing dysphagia\u002Frecurrent vomiting that may interfere with oral medication intake.\n5. Major trauma\u002Fsurgery within 12 weeks before screening or planned major surgery during the study.\n6. Previous bone marrow\u002Fhematopoietic stem cell transplantation or solid organ transplantation (e.g., heart, lung, kidney, liver).\n7. Known\u002Fsuspected hereditary complement deficiency, or diagnosed primary\u002Fsevere secondary immunodeficiency.\n8. Poorly controlled blood pressure as assessed by the investigator.\n9. Poorly controlled blood glucose as assessed by the investigator.\n10. Presence of nephrotic syndrome, rapidly progressive glomerulonephritis, renal pathology showing \\>50% glomerular crescents, or \\>50% tubular atrophy-interstitial fibrosis.\n11. Participation in other interventional clinical trials with pharmacological\u002Fdevice interventions within 4 weeks before screening.\n12. Pregnant\u002Flactating women or those planning pregnancy during the study",{"count":110,"type":21},80,[25],"NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.",[114],"Primary IgA Nephropathy","2025-05-20",{"date":117,"type":33},"2025-05-21",{"date":119,"type":21},"2025-05",{"date":121,"type":21},"2026-09",{"name":39,"class":40},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":84},"100591232","clinical-study-on-the-effectiveness-and-safety-of-succinylated-gelatin-electrolyte-sodium-acetate-injection-100591232","NCT06977750","Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection","A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery","Inclusion Criteria:\n\n1. Age range is 18 to 65 years old (including boundary values), with no gender restrictions.\n2. Weight not less than 50 kg, weight not more than 100 kg, body mass index \\[BMI=weight (kg)\u002Fheight 2 (m2)\\] within the range of 19.0\\~30.0 kg\u002Fm2 (including critical values).\n3. Planned elective surgery with an estimated duration of less than 6 hours.\n4. The expected ANH blood collection volume is 10% to 15% of the total blood volume.\n5. Prior to enrollment, the Hb level of the subjects was ≥ 110 g\u002FL.\n6. The American Society of Anesthesiologists (ASA) has a rating of I-III.\n7. Voluntarily participate in this experiment and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.\n2. Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis), and the researchers have determined that they are not suitable to participate in this trial.\n3. Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6 months before screening), myocardial infarction (within 6 months before screening), New York Heart Association (NYHA) classification ≥ III, congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placing heart stents or abnormal results of echocardiography and\u002For 12 lead electrocardiogram during screening, has clinical significance.\n4. Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such as angiotensin-converting enzyme inhibitors\u002Fangiotensin II receptor antagonists and potassium sparing diuretics 10 hours before surgery, and the researchers have determined that they are not suitable to participate in this trial.\n5. Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\\>2 times the upper limit of normal values; Albumin level\\\u003C35 g\u002FL; Blood bilirubin is greater than 1.5 times the upper limit of normal value.\n6. Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\\>1.5 times the upper limit of normal values.\n7. There are any of the following respiratory management risks during screening: 1) history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleep apnea syndrome;\n8. Hematological disorders such as sickle cell anemia, thalassemia, and pheochromocytoma.\n9. There is a significant risk of bleeding or coagulation disorders, and the researchers assess that surgery is not suitable, including but not limited to: a) past\u002Fcurrent thrombotic or thromboembolic events, or an increased risk of thrombotic or thromboembolic events; b) Require the use of antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) other than aspirin (up to 100 mg\u002Fd); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) PT prolongation\\>upper limit of normal value of 3 seconds or APTT prolongation\\>upper limit of normal value of 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\\\u003C80 × 109\u002FL.\n10. Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and the investigator judged that they were not suitable to participate in the trial.\n11. History of malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).\n12. Excessive blood volume (such as polycythemia vera) and fluid overload (such as systemic edema).\n13. There is an active infection with poor control, which the researchers believe makes the subjects unsuitable to participate in this clinical study.\n14. Preoperative complications include pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc.\n15. When screening, there is a water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) and the researcher believes that the abnormality has clinical significance and is not suitable to participate in this clinical study.\n16. Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.\n17. Received anemia related treatment, colloidal solution, and\u002For blood products 14 days before surgery.\n18. Those who have received the vaccine within one month before surgery.\n19. Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).\n20. Has a history of drug abuse in the past.\n21. Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter).\n22. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan or are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine device or condom) during the study period until 1 month after the last use of medication.\n23. Those who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;\n24. Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.","65 Years",{"count":132,"type":21},104,[134],"NA","The succinylated gelatin electrolyte sodium acetate injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical. is used as the experimental drug, and the succinylated gelatin electrolyte sodium acetate injection (trade name: Jialeban) produced and licensed by Braun Medical (Suzhou) Co., Ltd ®； Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.",[137],"Acute Normovolemic Hemodilution","RECRUITING","2025-05-11",{"date":141,"type":33},"2025-05-18",{"date":143,"type":33},"2025-04-27",{"date":145,"type":21},"2025-12-31",{"name":39,"class":40},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100591233","clinical-study-on-the-effectiveness-and-safety-of-succinylated-gelatin-injection-100591233","NCT06977763","Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection","A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery","Inclusion Criteria:\n\n1. Age range is 18 to 65 years old (including boundary values), with no gender restrictions.\n2. Weight not less than 50 kg, weight not more than 100 kg, body mass index \\[BMI=weight (kg)\u002Fheight 2 (m2)\\] within the range of 19.0\\~30.0 kg\u002Fm2 (including critical values).\n3. Planned elective surgery with an estimated duration of less than 6 hours.\n4. The expected ANH blood collection volume is 10% to 15% of the total blood volume.\n5. Prior to enrollment, the Hb level of the subjects was ≥ 110 g\u002FL.\n6. The American Society of Anesthesiologists (ASA) has a rating of I-III.\n7. Voluntarily participate in this experiment and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.\n2. Individuals who have a history of heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as arteriosclerosis) and are deemed unsuitable to participate in this trial by the researchers.\n3. Suffering from severe heart disease, including but not limited to a history of unstable angina, cerebrovascular accident or transient ischemic stroke (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placement of cardiac stents or New York Heart Association (NYHA) classification ≥ III at the time of screening, abnormal results on echocardiography and\u002For 12 lead electrocardiogram have clinical significance.\n4. Patients who have previously suffered from pheochromocytoma or had poor blood pressure control during screening (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg), and the researchers have determined that they are not suitable to participate in this trial.\n5. Individuals with a history of liver cirrhosis or abnormal liver function during screening and deemed unsuitable for participation in this trial by the researchers: AST or ALT\\>2 times the upper limit of normal values; Albumin level\\\u003C35 g\u002FL; Blood bilirubin is greater than 1.5 times the upper limit of normal value.\n6. Having any of the following respiratory management risks in the past: 1) history of asthma (such as allergic asthma); 2) People with sleep apnea syndrome.\n7. Previously suffered from hematological disorders such as sickle cell anemia, thalassemia, etc.\n8. Patients with previous or current malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).\n9. There is a significant risk of bleeding or coagulation disorders, and the researcher evaluates those who are not suitable to participate in this trial, including but not limited to: a) past\u002Fcurrent thrombosis or thromboembolic events; b) Patients who stop using antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) before surgery and have not reached a half-life of 7 days or more (whichever is shorter), except for aspirin (up to 100 mg\u002Fd) and low molecular weight heparin (routine prophylactic use before surgery); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) When screening, PT extension\\>upper limit of normal value for 3 seconds or APTT extension\\>upper limit of normal value for 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\\\u003C80 × 109\u002FL during screening.\n10. Individuals with abnormal renal function assessment during screening and deemed unsuitable for participation in this trial by the researchers: Cr or BUN\\>1.5 times the upper limit of normal values.\n11. Individuals with excessive fluid load during screening (such as systemic edema) and deemed unsuitable for participation in this trial by the researchers.\n12. There were active infections with poor control during screening, and the researchers deemed it unsuitable to participate in this trial.\n13. During screening, pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc. are combined.\n14. Individuals with water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) during screening and deemed clinically significant by the researchers are not suitable to participate in this trial.\n15. Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.\n16. Received anemia related treatment, colloidal solution, and\u002For blood products 14 days before surgery.\n17. If corticosteroids or nonsteroidal anti-inflammatory drugs cannot be discontinued within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter), or if drugs that affect the subject's blood volume cannot be discontinued within 1 day before surgery (such as mannitol, etc.).\n18. Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).\n19. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan during the study period until 1 month after the last use of medication, or who are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine devices or condoms) during the study period until 1 month after the last use of medication.\n20. Individuals who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;\n21. Other situations that the researcher deems unsuitable to participate in this experiment.",{"count":132,"type":21},[134],"The succinylated gelatin injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical.. is used as the experimental drug, and the succinylated gelatin injection (trade name: Gelofusine) produced by B. Braun Melsungen AG is licensed ®； Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.",[137],{"date":141,"type":33},{"date":160,"type":21},"2025-07-01",{"date":162,"type":21},"2025-12-01",{"name":39,"class":40},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":84},"100559166","phase-1-a-phase-1-clinical-trial-of-ntq5082-in-healthy-volunteers-100559166","NCT06560593","A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers","A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics\u002FPharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses","Inclusion Criteria:\n\n1. Healthy male or female, ≥18 years and ≤45 years in age.\n2. 19.0 kg\u002Fm2≤BMI≤26.0 kg\u002Fm2, and male weight must be ≥50 kg, female weight must be ≥45 kg;\n3. Those who sign an informed consent form before the experiment and fully understand the content, process, and possible adverse reactions of the experiment;\n4. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.\n\n3\\. (Part 2 only) The Subjects voluntarily receive ACYW135 group meningococcal vaccine and pneumococcal vaccine at least 14 days before NTQ5082 capsule administration. If the subjects has received pneumococcal vaccine within 5 years, or ACYW135 group meningococcal vaccine within 3 years, repeated vaccination is not required.\n\nExclusion Criteria:\n\n1. Participants who have participated in any other drug clinical trials and used the investigational drug within 3 months prior to the trial;\n2. Individuals who have chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years, and who are still clinically significant according to researchers;\n3. Individuals with clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);\n4. Known or suspected history of immunodeficiency (such as frequent recurrent infections), genetic or acquired complement deficiency;\n5. There is a clear history of capsule microbial infection within the first 6 months of screening; Including but not limited to: history of infection with Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila;\n6. Individuals with a history of tuberculosis infection or currently suffering from tuberculosis infection;\n7. Active systemic bacterial, viral, or fungal infection within 14 days prior to administration;\n8. Fever (≥ 38 ℃) occurred within 7 days before administration;\n9. Individuals with a history of allergies to experimental preparations, any of their components or related preparations, or to drugs, food or other substances;\n10. Those who cannot tolerate venous puncture or have a history of dizziness or needle fainting;\n11. Patients who have undergone surgery within 6 months prior to the use of the investigational drug, as determined by the researcher, that may affect drug absorption, distribution, metabolism, and excretion; Or have undergone surgical procedures within 4 weeks prior to using the investigational drug; Or those who plan to undergo surgical procedures during the trial period;\n12. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 2 weeks before using the study drug; Or screen for drugs with a duration of less than 5 half lives (whichever is longer);\n13. Individuals who have received the vaccine or live attenuated vaccine within 14 days prior to using the investigational drug, or who plan to receive the vaccine during the trial period;\n14. Individuals with QTc\\>450 milliseconds (male) or QTc\\>470 milliseconds (female) during screening;\n15. Individuals who have donated blood or experienced significant blood loss (\\>400mL) within 3 months prior to the use of the investigational drug, those who have received blood transfusions or used blood products, or those who intend to donate blood or blood components during or within 3 months after the end of the trial;\n16. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within the past year before using research drugs; Or those who test positive for urinary toxicity screening;\n17. Smokers or those who have smoked more than 5 cigarettes per day in the 3 months prior to using the study drug, or those who cannot stop using any tobacco products during the trial period;\n18. Alcoholics or frequent drinkers within the 6 months prior to the experiment, who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Those who are unwilling to stop drinking alcohol or any alcoholic products during the trial period; Or those who test positive for alcohol breath test;\n19. Individuals who consume excessive amounts of tea, coffee, and\u002For caffeinated beverages (8 or more cups, 1 cup=250 mL) daily, or who do not agree to stop drinking tea, coffee, and\u002For caffeinated beverages during the trial period;\n20. Individuals who consume a diet (including grapefruit or grapefruit products, etc.) that may affect the metabolism of the investigational drug within 7 days prior to use, or who are deemed by the researcher to have other diets that may affect the absorption, distribution, metabolism, or excretion of the drug, or who do not agree to stop consuming the aforementioned foods during the trial period;\n21. Those who have special dietary requirements and cannot follow a uniform diet;\n22. Female subjects are pregnant or breastfeeding women; Or engaging in unprotected sexual activity within 2 weeks prior to the use of the investigational drug; Those who have used oral contraceptives within 30 days prior to the use of the study drug, or those who have used long-acting estrogen or progesterone injections or implants within 6 months prior to the use of the study drug;\n23. If the subject (or their partner) has a pregnancy plan, sperm and egg donation plan, or is unwilling to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive rings, partner ligation, etc.) within 3 months after the last dose of medication from the time of signing the informed consent form;\n24. Physical examination, electrocardiogram, abdominal ultrasound, chest radiograph, laboratory tests (blood routine, reticulocyte count, procalcitonin, high-sensitivity C-reactive protein, urine routine, blood biochemistry, thyroid function, coagulation function, D-dimer, blood transfusion, blood pregnancy), vital signs, and clinically significant abnormalities in various examinations (subject to the judgment of the research doctor);\n25. Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.",true,"45 Years",{"count":174,"type":21},82,[24],"NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK\u002FPD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.",[178],"Complement-mediated Hemolytic Diseases","2024-08-16",{"date":181,"type":33},"2024-08-19",{"date":183,"type":21},"2024-08",{"date":185,"type":21},"2025-02",{"name":39,"class":40},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":172,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":203,"locationsCount":84},"100559017","phase-1-effect-of-food-of-ntq5082-in-healthy-subjects-100559017","NCT06558656","Effect of Food of NTQ5082 in Healthy Subjects","A Randomized, Open Label, Two Sequence, Two Period, Double Crossover-design Phase I Clinical Trial of NTQ5082 Capsules Taken by Healthy Subjects on an Empty Stomach (i.e, Fasting) as Well as After a Meal (i.e. Fed)","Inclusion Criteria:\n\n1. Healthy male or female, ≥18 years and ≤45 years in age.\n2. 19.0 kg\u002Fm2≤BMI≤26.0 kg\u002Fm2, and male weight must be ≥50 kg, female weight must be ≥45 kg;\n3. Those who sign an informed consent form before the experiment and fully understand the content, process, and possible adverse reactions of the experiment;\n4. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.\n\nExclusion Criteria:\n\n1. Participants who have participated in any other drug clinical trials and used the investigational drug within 3 months prior to the trial;\n2. Individuals who have chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years, and who are still clinically significant according to researchers;\n3. Individuals with clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);\n4. Known or suspected history of immunodeficiency (such as frequent recurrent infections), genetic or acquired complement deficiency;\n5. There is a clear history of capsule microbial infection within the first 6 months of screening; Including but not limited to: history of infection with Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila;\n6. Individuals with a history of tuberculosis infection or currently suffering from tuberculosis infection;\n7. Active systemic bacterial, viral, or fungal infection within 14 days prior to administration;\n8. Fever (≥ 38 ℃) occurred within 7 days before administration;\n9. Individuals with a history of allergies to experimental preparations, any of their components or related preparations, or to drugs, food or other substances;\n10. Those who cannot tolerate venous puncture or have a history of dizziness or needle fainting;\n11. Patients who have undergone surgery within 6 months prior to the use of the investigational drug, as determined by the researcher, that may affect drug absorption, distribution, metabolism, and excretion; Or have undergone surgical procedures within 4 weeks prior to using the investigational drug; Or those who plan to undergo surgical procedures during the trial period;\n12. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 2 weeks before using the study drug; Or screen for drugs with a duration of less than 5 half lives (whichever is longer);\n13. Individuals who have received the vaccine or live attenuated vaccine within 14 days prior to using the investigational drug, or who plan to receive the vaccine during the trial period;\n14. Individuals with QTc\\>450 milliseconds (male) or QTc\\>470 milliseconds (female) during screening;\n15. Individuals who have donated blood or experienced significant blood loss (\\>400mL) within 3 months prior to the use of the investigational drug, those who have received blood transfusions or used blood products, or those who intend to donate blood or blood components during or within 3 months after the end of the trial;\n16. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within the past year before using research drugs; Or those who test positive for urinary toxicity screening;\n17. Smokers or those who have smoked more than 5 cigarettes per day in the 3 months prior to using the study drug, or those who cannot stop using any tobacco products during the trial period;\n18. Alcoholics or frequent drinkers within the 6 months prior to the experiment, who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Those who are unwilling to stop drinking alcohol or any alcoholic products during the trial period; Or those who test positive for alcohol breath test;\n19. Individuals who consume excessive amounts of tea, coffee, and\u002For caffeinated beverages (8 or more cups, 1 cup=250 mL) daily, or who do not agree to stop drinking tea, coffee, and\u002For caffeinated beverages during the trial period;\n20. Individuals who consume a diet (including grapefruit or grapefruit products, etc.) that may affect the metabolism of the investigational drug within 7 days prior to use, or who are deemed by the researcher to have other diets that may affect the absorption, distribution, metabolism, or excretion of the drug, or who do not agree to stop consuming the aforementioned foods during the trial period;\n21. Those who have special dietary requirements and cannot follow a uniform diet;\n22. Female subjects are pregnant or breastfeeding women; Or engaging in unprotected sexual activity within 2 weeks prior to the use of the investigational drug; Those who have used oral contraceptives within 30 days prior to the use of the study drug, or those who have used long-acting estrogen or progesterone injections or implants within 6 months prior to the use of the study drug;\n23. If the subject (or their partner) has a pregnancy plan, sperm and egg donation plan, or is unwilling to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive rings, partner ligation, etc.) within 3 months after the last dose of medication from the time of signing the informed consent form;\n24. Physical examination, electrocardiogram, abdominal ultrasound, chest radiograph, laboratory tests (blood routine, reticulocyte count, procalcitonin, high-sensitivity C-reactive protein, urine routine, blood biochemistry, thyroid function, coagulation function, D-dimer, blood transfusion, blood pregnancy), vital signs, and clinically significant abnormalities in various examinations (subject to the judgment of the research doctor);\n25. Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.",{"count":195,"type":21},12,[24],"NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral administration of NTQ5082 capsules and the safety and tolerability of single oral administration of NTQ5082 capsules on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy subjects",[178],"2024-08-14",{"date":181,"type":33},{"date":183,"type":21},{"date":185,"type":21},{"name":39,"class":40},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100555459","phase-3-a-study-of-ramelteon-in-chinese-patients-with-chronic-insomnia-100555459","NCT06512363","A Study of Ramelteon in Chinese Patients With Chronic Insomnia","A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years old.\n* Chronic insomnia disorder diagnosed according to International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) criteria.\n* Self-reported history of all the following on at least 3 nights per week within 4 weeks prior to screening: subjective sleep latency (sSL) greater than or equal to 30 minutes, and subjective total sleep time (sTST) less than or equal to 6.5 hours per night.\n* Meeting all the following sleep parameters on the 2 PSG nights during the run-in period: mean latency to persistent sleep (LPS) ≥ 20 min (with neither of the two nights \\\u003C 15 min), and mean wake after sleep onset (WASO) ≥ 30 min (with neither of the two nights \\\u003C 20 min).\n* Usual bedtime between 20:30 and 01:00, and regular time in bed between 6.5 and 9 h.\n* Insomnia Severity Index score≥15 at screening and on Day 1 of the treatment period.\n* Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.\n\nExclusion Criteria:\n\n* Use of ramelteon within 30 days prior to screening.\n* Previous non-responders to melatonin receptor agonist therapy.\n* Known hypersensitivity to ramelteon or related compounds, including melatonin.\n* Sleep schedule changes required by employment (e.g. shift worker), or has flown across greater than three time zones (mainland China is considered as 1 time zone) within 30 days prior to screening and during the study period; or special professionals who need to operate machinery during the study period, such as professional drivers, high-altitude operators, etc.\n* Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to screening and during the study period.\n* Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.\n* Previous history of other sleep disorders secondary to other diseases including moderate to severe obstructive sleep apne, circadian rhythm sleep disturbances, paroxysmal sleeping sickness, and restless legs syndrome.\n* Apnea-hypopnea index (AHI) and periodic limb movement index (PLMI) \\> 15 times\u002Fhour detected by PSG monitoring during the run-in period.\n* Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.\n* Hamilton Anxiety Scale (HAMA) score ≥ 14 and Hamilton Depression Scale (HAMD) score ≥ 18 at screening.\n* Have serious diseases of cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, immune system, etc., which are not suitable for the study judged by the investigators.\n* AST or ALT \\> 3 × ULN, and TBIL \\> 2 × ULN.\n* Patients with HIV or syphilis infection.\n* Use of any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, strong CYP1A2 inhibitors, strong CYP2C9 inhibitors, strong CYP3A4 inhibitors, strong CYP inducers, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.\n* Requirement of taking any prohibited medication during study period.\n* History of drug abuse within 1 year prior to screening, or positive urine drug screening.\n* History of alcohol abuse within 1 year prior to screening, or unwilling to follow alcohol restriction during the study period.\n* Regular daily consumption of excessive tea and coffee drinks, or unwilling to follow tea\u002Fcoffee restriction during the study period.\n* History of smoking addiction or unwilling to follow tobacco restriction during the study period.\n* Participated in any other investigational study and taken any investigational drug within 1 month or 5 half-lives prior to screening, whichever is longer.\n* Pregnant or lactating women, or planning to have children or both men of reproductive potential and women of childbearing potential disagree to use ≥1 effective contraception throughout the study and within 3 months after the end of the study.\n* MEQ-19 score ≤ 49.\n* Other conditions that are not considered appropriate by the investigator.",{"count":212,"type":21},280,[51],"The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.\n\nEfficacy will be evaluated on objective and subjective sleep parameters.",[216],"Chronic Insomnia","2024-07-16",{"date":219,"type":33},"2024-07-22",{"date":183,"type":21},{"date":222,"type":21},"2026-12",{"name":39,"class":40},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":84},"100519908","phase-1-a-phase-1-clinical-trail-of-ntq2494-tablets-in-patients-with-advanced-hematological-malignancies-100519908","NCT06049667","A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics and Preliminary Efficacy of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies","Inclusion Criteria:\n\n1. ≥18 years in age, male or female.\n2. Relapsed\u002Frefractory AML patients.\n3. ECOG performance status score is 0 to 2.\n4. Life expectancy of at least 3 months.\n5. Adequate bone marrow and good organ function.\n6. Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.\n2. Receiving any other investigational agents within 4 weeks prior to starting study treatment.\n3. Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.\n4. AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.\n5. Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and\u002For other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for \\> 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.\n6. Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior to starting study treatment.\n7. Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatment and\u002For planning to receive (attenuated) live vaccines during the trial.\n8. With unresolved clinically significant non-hematological toxicities from prior AML therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery), defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events that are tolerable as judged by the investigator.\n9. Patients who have received previous allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.\n10. Unable to swallow oral tablets, or other conditions seriously affecting gastrointestinal absorption judged by the investigator.\n11. Patients with uncontrolled infections unsuitable for the trail judged by the investigator.\n12. Known infection with hepatitis B, hepatitis C, HIV or Syphilis.\n13. Known alcohol or drug dependence.\n14. Patients with mental disorders or poor compliance.\n15. Patients with a previous history of severe allergy to any drug or food.\n16. Lactating or pregnant female, and females or males (or partners) who plan to pregnant and do not agree to use adequate contraception for the duration of the trail and up to 3 months after completion of the last study treatment.\n17. Other reasons judged by the investigator that the patients unsuitable for the trail.",{"count":232,"type":21},72,[24],"NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor.\n\nThe objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.",[236],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)","2023-09-17",{"date":239,"type":33},"2023-09-22",{"date":241,"type":33},"2023-08-07",{"date":243,"type":21},"2026-08",{"name":39,"class":40},""]