[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Synvida Biotechnology Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100629010","phase-1-a-clinical-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-sv003-in-healthy-participants-100629010",false,"NCT07469085","A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.","A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.","Inclusion Criteria:\n\n1. Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg\u002Fm², 18.5 ≤ Caucasian participants ≤ 32 kg\u002Fm²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;\n2. Healthy status: No evidence of active or chronic diseases in participants;\n3. Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.\n\nExclusion Criteria:\n\n1. Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;\n2. Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;\n3. Subjects with designated examination results reaching a specified value;\n4. Subjects with abnormal laboratory test results deemed clinically significant by the investigator;\n5. Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;\n6. Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;\n7. Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;\n8. Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;\n9. Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use;\n10. Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;\n11. Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;\n12. Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;\n13. Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;\n14. Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration;\n15. Any other factors that the investigator deems may render a subject unsuitable for study participation.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.",[28],"Healthy Participants","RECRUITING","2026-04-07",{"date":32,"type":33},"2026-04-08","ACTUAL",{"date":35,"type":33},"2026-04-04",{"date":37,"type":22},"2027-03-31",{"name":39,"class":40},"Shanghai Synvida Biotechnology Co.,Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100536619","early-phase-1-a-clinical-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-sv001-in-chinese-healthy-adult-volunteers-100536619","NCT06267183","A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.","Inclusion Criteria:\n\n1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;\n2. Subjects must have a Body Mass Index in the range of 19\\~26 kg\u002Fm2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;\n3. Subjects must be in good health as judged by the investigator.\n4. Reliable contraception must be assured during and for some time after the trial.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other substance anaphylaxis;\n2. Subjects with respiratory symptoms or abnormal respiratory tract;\n3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;\n4. Subjects with other diseases or factors with abnormal clinical manifestations;\n5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;\n6. Subjects who smoked more than 5 cigarettes a day in the period before screening;\n7. Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;\n8. Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;\n9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;\n10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;\n11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.\n12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;\n13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;\n14. Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;\n15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;\n16. Any other status in which the investigator deems inappropriate to participate in the present study.",{"count":50,"type":22},53,[52],"EARLY_PHASE1","The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.",[55],"Idiopathic Pulmonary Fibrosis","2026-03-09",{"date":58,"type":33},"2026-03-11",{"date":60,"type":33},"2024-01-12",{"date":62,"type":22},"2026-12-30",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100602277","phase-2-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-sv001-in-patients-with-idiopathic-pulmonary-fibrosis-100602277","NCT07121413","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;\n2. Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;\n3. Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;\n2. Presence of any other clinically significant pulmonary diseases besides IPF at screening;\n3. Any known contraindications to performing pulmonary function tests at screening;\n4. Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;\n5. Acute exacerbation of IPF within 4 months prior to randomization;\n6. Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;\n7. History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;\n8. Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;\n9. Presence of specified abnormal laboratory test results at screening;\n10. Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;\n11. Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;\n12. History of malignancy within 5 years prior to screening;\n13. Difficulty with venipuncture or a history of needle phobia or blood phobia;\n14. Positive pregnancy tests or currently lactating at screening;\n15. Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;\n16. Any other condition that the investigator consider unsuitable for participation in the study.","40 Years",{"count":73,"type":22},48,[75],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.",[78],"Idiopathic Pulmonary Fibrosis(IPF)","2026-02-08",{"date":81,"type":33},"2026-02-11",{"date":83,"type":33},"2025-11-04",{"date":85,"type":22},"2026-12-31",{"name":39,"class":40},12,""]