[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Ark Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,78,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642133","phase-2-a-study-of-ziresovir-ak0529-in-high-risk-adult-with-respiratory-syncytial-virus-rsv-infection-100642133",false,"NCT07658534","A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.","A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b\u002F3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.","Inclusion Criteria:\n\n* Aged 18-85 years (inclusive), regardless of gender.\n* Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose.\n* Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years.\n* Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale).\n* Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom\u002Fsign confirmed by investigator; pre-existing symptoms are those due to underlying conditions)\n\nExclusion Criteria:\n\n* Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent.\n* Suspected bacterial co-infection.\n* Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study.\n* Received prohibited medications, or plans to use prohibited medications during the study.\n* Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy.\n* Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation.\n* Female participants with a positive pregnancy test result, or who are breastfeeding.\n* Refusal to use effective contraception during the trial period.","ALL","18 Years","85 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.",[28],"Respiratory Syncytial Virus Infections",[30,31,32,33,34],"Ziresovir","RSV","Chronic Respiratory Disease","Heart Disease","The Elderly","RECRUITING","2026-06-15",{"date":38,"type":39},"2026-06-22","ACTUAL",{"date":41,"type":39},"2026-03-03",{"date":43,"type":21},"2029-01",{"name":45,"class":46},"Shanghai Ark Biopharmaceutical Co., Ltd.","INDUSTRY",9,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100626212","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-ak0406-injection-in-healthy-adult-participants-100626212","NCT07432698","A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants","A Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of AK0406 in Healthy Adult Participants","Inclusion Criteria:\n\n* Male or female participants aged 18 to 65 years (inclusive) at the time of formed consent.\n* At screening, male participants must weigh ≥50 kilogram (kg), and female participants must weigh ≥45 kg, with a body mass index between 18.0 and 32.0 kilograms per square meter (kg\u002Fm²) (inclusive).\n* Participants must be in good general health as determined by the investigator, with no clinically significant abnormalities in vital signs, 12-lead electrocardiogram (ECG), or laboratory tests.\n* Woman of childbearing potential (WOCBP) and male participants whose female sexual partner is WOCBP must agree to use highly effective contraception from the day of study drug administration until 6 months after dosing and must agree to avoid sperm or oocyte donation and not plan to conceive during this period.\n* Participants must voluntarily agree to participate, be able to communicate effectively with the investigator, understand and comply with study requirements, and provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disease, or any other condition that, in the opinion of the investigator, may compromise participant safety, interfere with study results, or prevent completion of the study.\n* Active malignancy or history of malignancy (except adequately treated basal cell carcinoma with no evidence of recurrence).\n* History of congenital or acquired immunodeficiency.\n* Acute illness (e.g., fever, infectious disease, diarrhea) within 7 days prior to first dosing.\n* Major surgery within 3 months before screening or planned major surgery within 6 months after study drug administration.\n* Known hypersensitivity to neuraminidase inhibitors (e.g., oseltamivir, zanamivir, peramivir), or to AK0406 active ingredient or any excipients.\n* Anaphylaxis or severe hypersensitivity (e.g., hypotension, dyspnea, severe angioedema).\n\nDiagnostic Assessments\n\n* Positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, Hepatitis B surface antigen (HBsAg), or Treponema pallidum antibody.\n* Systolic blood pressure \\>140 millimeters of mercury (mmHg) or ≤90 mmHg, diastolic blood pressure ≥90 mmHg or ≤50 mmHg, or pulse ≤45 or ≥110 beats per minute (bpm) while awake and at rest.\n* The Corrected QT interval by Fredericia (QTcF) prolongation (up to 450 ms in males \u002F 470 milliseconds (ms) in females) at screening. \\[QTcF = QT\u002F(RR\\^0.33)\\] (RR = 60\u002Fheart rate)",true,"65 Years",{"count":58,"type":21},32,[60],"PHASE1","This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult participants.",[63],"Healthy Participants",[65,66,67],"Pharmacokinetics","Safety","Tolerability","NOT_YET_RECRUITING","2026-02-24",{"date":71,"type":39},"2026-02-25",{"date":73,"type":21},"2026-02",{"date":75,"type":21},"2027-04",{"name":45,"class":46},1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":77},"100592690","phase-1-a-clinical-study-of-ak0610-100592690","NCT06996704","A Clinical Study of AK0610","A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.","Inclusion Criteria:\n\n1. Participants aged 18 - 50 (both males and females)\n2. Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg\u002Fm2.\n3. Assessed by the investigator to be in good health with no clinically significant abnormalities.\n4. Use of highly effective contraception within 1 year of administration.\n5. Voluntary participation in clinical research and signing of written informed consent.\n\nExclusion Criteria:\n\n1. Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.\n2. Active malignancy and\u002For a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)\n3. History of congenital or acquired immunodeficiency.\n4. Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.\n5. Major surgery within 3 months prior to screening or major surgery planned within 1 year of study drug administration.\n6. Hypersensitivity to the active ingredient of AK0610 or any excipients.\n7. Previous history of allergy to biologics or history of severe allergic reaction (e.g. hypotension, dyspnea, severe angioedema) to any drug.\n8. Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive or hepatitis B surface antigen (HBsAg) positive; syphilis spirochete antibody positive.\n9. Systolic blood pressure ≥140 mmHg or \\\u003C90 mmHg or diastolic blood pressure ≥90 mmHg or \\\u003C60 mmHg, and pulse \\\u003C55 or \\>100 beats\u002Fmin.\n10. ECG suggestive of prolonged QTcF (≥450 ms in both women and men). \\[QTcF= QT\u002F(RR\\^0.33)\\]\n11. Use of any prescription, over-the-counter, herbal, proprietary, or health care product (other than birth control pills) within 14 days prior to study drug administration.\n12. Have received treatment with immune globulin or other blood products within 6 months prior to study drug administration\n13. Have received treatment with monoclonal antibodies or other biological products within 6 months prior to administration of study drug.\n14. Have received a live attenuated vaccination within 1 month prior to study drug administration, has received another vaccination within 14 days, or is scheduled to receive a vaccination within 1 year of study drug administration.\n15. Received any other investigational drug therapy within 3 months (or 5 half-lives, whichever is longer) prior to study drug administration, or plans to participate in another study within 1 year of study drug administration.\n16. Participating or have participated in another interventional clinical study of a monoclonal antibody or vaccine against RSV.","50 Years",{"count":87,"type":21},136,[60],"The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.",[91],"Healthy Volunteer Study",[93],"Phase 1 study of AK0610","2025-05-21",{"date":96,"type":39},"2025-05-30",{"date":98,"type":39},"2024-02-29",{"date":100,"type":21},"2025-09",{"name":45,"class":46},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":122,"locationsCount":123},"100575678","phase-3-a-study-to-confirm-the-effectiveness-and-safety-of-ak0529-in-treating-rsv-infections-in-hospitalized-infants-100575678","NCT06775405","A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants","A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection","Main Inclusion criteria:\n\n1. Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.\n2. Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.\n3. The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.\n4. Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards.\n5. Subject must have a Wang bronchiolitis clinical score ≥ 5.\n\nMain Exclusion criteria:\n\n1. The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours.\n2. Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .\n3. Subject is known to have bacterial pneumonia.\n4. Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).\n5. Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases).\n6. Subject with chronic or persistent feeding difficulties.\n7. The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his\u002Fher staff.\n8. Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening.\n9. Subject with any other reason that the investigator deems unsuitable for participation in the study.","1 Month","24 Months",{"count":112,"type":21},180,[25],"Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.",[116],"Respiratory Synctial Virus Infections","2025-01-09",{"date":119,"type":39},"2025-01-15",{"date":98,"type":39},{"date":100,"type":21},{"name":45,"class":46},18,""]