[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Linno Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,62],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100635500","phase-2-sln12140-in-adult-participants-with-iga-nephropathy-in-china-100635500",false,"NCT07553494","SLN12140 in Adult Participants With IgA Nephropathy in China","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SLN12140 in Adult Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n* The subject has fully understood the purpose, nature, methods and potential adverse reactions of this trial, volunteers to participate as a subject, is able to communicate effectively with the investigators, understands and complies with all requirements of this study, and voluntarily signs the Informed Consent Form (ICF) prior to initiation of any study procedures.\n* Male and female subjects aged 18 to 80 years (inclusive) at the time of signing the ICF, with body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) 18.0-35.0 kg\u002Fm² (inclusive).\n* Patients with IgA nephropathy confirmed by biopsy within the past 3 years before screening, with renal tubulointerstitial fibrosis \\\u003C 50%.\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m² during the screening period, calculated using the 2021 creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* During the screening period, 24-hour urine protein-to-creatinine ratio (24h UPCR) ≥ 1.0 g\u002Fg; after completion of the run-in period, UPCR ≥ 0.75 g\u002Fg or urine protein excretion (UPE) ≥ 0.75 g\u002Fday.\n* Must have received standard of care therapy for at least 12 weeks (and at a stable dose for at least 4 weeks) prior to the first dose of study medication, and agree to maintain stable dosing throughout the study period. (Note: Permitted standard of care medications in this study include ACEi\u002FARB and SGLT2i.)\n* Males and women of childbearing potential (WOCBP; as defined by the Clinical Trials Facilitation and Coordination Group \\[CTFG\\] 2020) must agree to follow the contraception guidelines specified in the protocol from the screening period until 6 months after the last dose of study medication.\n* The subject is willing to receive quadrivalent meningococcal vaccine and pneumococcal vaccine at least 14 days before dosing (for subjects vaccinated within 14 days before dosing, antibiotic prophylaxis for at least 14 days is required after the first vaccination). Re-vaccination is not required for those who have received quadrivalent meningococcal vaccine within 3 years before the first dose, or pneumococcal vaccine within 5 years before the first dose.\n\nExclusion Criteria:\n\n* A known history of hypersensitivity, allergy, or anaphylactic reaction to any component of the investigational product, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.\n* Secondary IgA nephropathy as determined by the investigator, such as that caused by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, ankylosing spondylitis, infection, or other etiologies.\n* Diagnosis of IgA vasculitis.\n* Current presence or history of nephrotic syndrome.\n* Clinical suspicion of IgA nephropathy with rapidly progressive glomerulonephritis in accordance with the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines (≥50% decline in eGFR within 3 months prior to ICF signature, or a \\\u003C50% decline but at risk of rapid renal function deterioration as assessed by the investigator).\n* Clinical suspicion or biopsy-confirmed chronic kidney disease caused by any disease other than IgA nephropathy, including other glomerulopathies or podocytopathies.\n\nOther protocol-defined exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors \\[ACEi\\], angiotensin II receptor blockers \\[ARB\\], and sodium-glucose co-transporter 2 inhibitors \\[SGLT2i\\]) but have poor control.\n\nThe study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group \\[the optimal dose\\], including a 52-week open treatment period and a 4-week safety follow-up period).",[27],"IgA Nephropathy (IgAN)","NOT_YET_RECRUITING","2026-04-20",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":21},"2026-05-29",{"date":36,"type":21},"2028-12",{"name":38,"class":39},"Linno Pharmaceuticals, Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100622721","phase-2-sln12140-in-adult-participants-with-paroxysmal-nocturnal-hemoglobinuria-pnh-in-china-100622721","NCT07387302","SLN12140 in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China","A Phase II Clinical Study Evaluating SLN12140 in Complement Inhibitor-Naïve Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria","Inclusion Criteria:\n\n* Adult complement inhibitor naïve PNH patients (age\\>=18), which is confirmed by flow cytometry evaluation\n* Must be vaccinated against meningococcal vaccine and pneumococcal vaccine\n\nExclusion Criteria:\n\n* Significant bone marrow failure\n* Meningitidis infection or unresolved meningococcal disease\n* Other significant systemic diseases that might have impact on efficacy and safety assessment",{"count":49,"type":21},10,[24],"The goal of this clinical trial is to learn if drug SLN12140 works to treat Complement Inhibitor-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria in adults. It will also learn about the safety, pharmacokinetic characteristics, and dosing of drug SLN12140.\n\nThe study is divided into four phases: screening period, core treatment period, extended dosing period, and follow-up period, and includes two cohorts (Cohorts 1-2), with each cohort enrolling at least 5 treatment-naïve adult PNH subjects for complement inhibitor therapy.",[53],"Paroxysmal Nocturnal Hemoglobinuria (PNH)","2026-01-27",{"date":56,"type":32},"2026-02-04",{"date":58,"type":21},"2026-02-10",{"date":60,"type":21},"2027-12-31",{"name":38,"class":39},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100588749","phase-1-study-of-sln12140-in-healthy-adult-participants-100588749","NCT06945445","Study of SLN12140 in Healthy Adult Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of SLN12140 Administered Subcutaneously or Intravenously in Healthy Adult Volunteers","Inclusion Criteria:\n\n1. Voluntarily participate in clinical trials and sign written informed consent, and be able to complete the whole trial process according to the requirements of the trial.\n2. Persons of any gender, aged between 18 and 65 years old (including the boundary value).\n3. Weight: male ≥50kg , female ≥45kg ; Body mass index (BMI) within the range of 19.0 to 28.0 kg\u002Fm2 (including cut-off values).\n4. Those whose medical history, physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, and anteroposterior chest X-ray are all normal or abnormal but non clinically significant as judged by the investigator.\n5. Participant has received the following vaccines:\n\n   * Meningococcal polysaccharide vaccine ACYW135 (MPV-ACYW) or meningococcal polysaccharide conjugate vaccine ACYW135 (MPCV-ACYW), given at least two weeks before the first dose and no earlier than within 2 years before the first dose;\n   * 13-valent pneumococcal conjugate vaccine (PCV13) or 23-valent pneumococcal polysaccharide vaccine (PPV23) at least two weeks before the first dose, and no earlier than 8 weeks before the first dose of PCV13 and no earlier than 4 years before the first dose of PPV23.\n6. Normal or abnormal but no clinical significance with ECG results ,such as QTcF interval ≤450ms (males) and QTcF interval ≤470ms (females); PR interval ≤ 209 ms; The QRS interval ≤ 120 ms.\n7. During the study period and within 3 months after the last dose of the study, there is no childcare plan and can take highly effective contraceptive measures and cannot donate sperm or eggs.\n\nExclusion Criteria:\n\n1. Have cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or nervous system diseases that affect the absorption, distribution, metabolism or elimination of drugs; or those with disease or medical history that may interfere with the interpretation of study data.\n2. Those who have any previous history of Neisseria meningitidis.\n3. Those who have a positive skin test for penicillin. Those who have known allergies or contraindications to penicillin or any vaccine ingredients, or who are known to be allergic to the trial drug and any of its ingredients or related preparations, or who have any history of allergies to food, drugs, or allergic diseases or allergies.\n4. Those who have or are suspected of having any active viral, bacterial, fungal or parasitic infection, or receiving any anti-infective treatment within 1 month prior to screening.\n5. Those with a history of recurrent or chronic infection (such as recurrent upper respiratory tract infection, diarrhea, etc.) within 3 months before screening.\n6. Within 1 month prior to screening, have received a live attenuated vaccine, or plan to receive a vaccine during the study (except for vaccinations required for the study).\n7. Received drugs that may interact with penicillin V potassium within 7 days or 5 elimination half-lives (whichever is longer) prior to dosing.\n8. Those who have any of the following abnormalities in laboratory tests during the screening stage:\n\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) exceeds the normal range;\n   * Total bilirubin (TBIL) ≥ 1.5 times the upper limit of normal (ULN);\n   * eGRF (CKD-EPI formula) \\\u003C90 mL\u002Fmin\u002F1.73m2;\n   * Hemoglobin \\\u003C lower limit of normal range (LLN).\n9. At the time of screening, the results of complement C3 and C4 examinations are lower than the lower limit of the normal reference value range and the abnormalities judged by the investigator to be clinically significant.\n10. Immunocompromised, or suffering from at least one of the following underlying diseases:\n\n    * Anatomical or functional asplenia (including sickle cell disease);\n    * Congenital complement deficiency (complement factor P deficiency, complement factor B deficiency, or complement factor D deficiency);\n    * Acquired complement deficiency;\n    * Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome.\n11. Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody (TPPA) and HIV antibody.\n12. Those who have donated or lost more than 400 mL of blood or have a history of blood transfusion within 30 days before screening or Day-1.\n13. Within 90 days prior to screening or Day-1, the participant has received investigational drug administration, or is currently participating in another clinical study (including the follow-up period).\n14. Participants who have used any prescription or over-the-counter medications, any vitamin products, or herbal remedies within 7 days prior to dosing.\n15. Those who have any history of intolerance to subcutaneous injection or related injection site scars (surgery, burns, tattoos, etc.) that would affect the evaluation of injectable drug administration.\n16. Those who are unwilling or unable to use antibiotic prophylaxis specified in the protocol.\n17. A person who falls under any of the following conditions:\n\n    * Professionals at high risk of exposure to meningococcal disease\n    * Research, industrial, or clinical laboratory personnel who are at risk of exposure to meningococcals\n    * Planned travel to areas where meningococcal is endemic (e.g., India, sub-Saharan Africa, Saudi Arabia) during the study period, or have traveled to these areas within 6 months of the day prior to the start of the study.\n18. A current or former drug abuser.\n19. Day-1 Positive Drug Abuse Screen.\n20. Those who have been an alcoholic within the current period of 3 months or in the past (drinking more than 14 standard units per week. 1 standard unit contains 14 g of alcohol, e.g. 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine).\n21. Those who have a positive Day-1 alcohol breath test (\\>0.0mg\u002F100mL).\n22. Use of more than 10 cigarettes (or equivalent nicotine-containing products) per week or more than 5 cigarettes (or equivalent nicotine-containing products) per day within 4 weeks prior to screening.\n23. Day-1 urine cortinine test positive.\n24. Those who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) within 24 hours before administration or have strenuous exercise, or other factors that affect the absorption, distribution, metabolism, and excretion of drugs.\n25. Pregnant or lactating female participants or those with a positive pregnancy test.\n26. Those who are unable to receive venipuncture, or faint blood and faint needles.\n27. Those who are considered by the investigator to have other factors that are not suitable for participating in the trial.",true,"18 Days","65 Days",{"count":73,"type":21},56,[75],"PHASE1","A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous\u002Fintravenous dose escalation and multiple subcutaneous administrations",[78],"Healthy Volunteer","2025-04-17",{"date":81,"type":32},"2025-04-25",{"date":83,"type":21},"2025-04",{"date":85,"type":21},"2026-06",{"name":38,"class":39},""]