[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658031":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":45,"interventions":56,"overallOfficials":34,"centralContacts":34,"locations":66,"responsibleParty":78,"collaborators":34,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":34,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":34,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":34,"overallStatus":100,"whyStopped":34,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":34},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"dose limited toxicity (DLT).","To determine the maximum tolerated dose (MTD) and\u002For RP2D.","Up to approximately 6 weeks.",{"measure":14,"description":15,"timeFrame":16},"Incidence of TEAE.","TEAE refers to 'treatment emergent adverse event'.","Up to approximately 25 weeks.",{"measure":18,"description":19,"timeFrame":16},"Incidence of TRAE.","Incidence of TEAE related to the experimental drug.",{"measure":21,"description":22,"timeFrame":23},"Incidence of SAE.","SAE refers to 'serious adverse event'.","Up to approximately 25 weeks",[25,28,31],{"measure":26,"description":27,"timeFrame":23},"Blood Concentrations of SCTB10","The pharmacokinetics of SCTB10 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)",{"measure":29,"description":30,"timeFrame":23},"Activated Partial Thromboplastin Time and Thrombin Generation Assay","pharmacodynamics",{"measure":32,"description":33,"timeFrame":23},"Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).","immunogenicity",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"TRIPLE",[42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[46,51],{"label":47,"type":48,"description":34,"interventionNames":49},"Placebo group","PLACEBO_COMPARATOR",[50],"Drug: Placebo",{"label":52,"type":53,"description":34,"interventionNames":54},"SCTB10 group","EXPERIMENTAL",[55],"Drug: SCTB10",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":34},"DRUG","SCTB10","SCTB10 will be subcutaneously administered as a single dose in healthy volunteers",[52],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"Placebo","Placebo will be subcutaneously administered in Healthy Volunteers",[47],[67],{"facility":68,"status":34,"city":69,"state":34,"zip":34,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":34},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","Tianjin","China","CN",{"type":73,"coordinates":74},"Point",[75,76],117.17667,39.14222,{"lat":76,"lon":75},{"type":79,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100658031","phase-1-a-phase-iii-clinical-trial-to-evaluate-the-safety-tolerability-pkpd-characteristics-and-efficacy-of-sctb10-100658031",false,"NCT07847697","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, PK\u002FPD Characteristics, and Efficacy of SCTB10","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Single and Multiple Doses of SCTB10 in Healthy Participants and Patients With Hemophilia A","Inclusion Criteria:\n\n1. Provision of written informed consent prior to initiation of any study procedures.\n2. Healthy male participants aged 18 to 50 years (inclusive).\n3. Body mass index (BMI) between 19 and 26 kg\u002Fm² (inclusive), and body weight ≥ 50 kg.\n4. Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.\n2. History of coronary and\u002For peripheral atherosclerosis, or congestive heart failure.\n3. Presence of high-risk factors for thrombosis.\n4. Clinically significant abnormal findings during screening, as determined by the investigator.\n5. Abnormal infectious disease screening results.\n6. Abnormal results in urine drug screening or breath alcohol test.\n7. Use of any medication or dietary supplements within 14 days prior to the first dose.\n8. Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.\n9. Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).",true,"MALE","18 Years","50 Years",{"count":92,"type":93},12,"ESTIMATED","INTERVENTIONAL",[96],"PHASE1","Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants",[99],"Healthy Participants","NOT_YET_RECRUITING","2026-09-23",{"date":103,"type":104},"2026-09-29","ACTUAL",{"date":106,"type":93},"2026-09-30",{"date":108,"type":93},"2029-08-30",{"name":5,"class":6},1]