[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640018":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":45,"locations":51,"responsibleParty":65,"collaborators":36,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":36,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":36,"studyType":81,"phases":82,"briefSummary":72,"conditions":84,"keywords":36,"overallStatus":54,"whyStopped":36,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Shanghai Argo Biopharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","BW-41012 (cohort 1, n=8)",[13],"Drug: BW-41012 injection or Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","BW-41012 (cohort 2, n=8)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","BW-41012 (cohort 3, n=8)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","BW-41012 (cohort 4, n=8)",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5","BW-41012 (cohort 5, n=8)",[13],[31,37,39,41,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","BW-41012 injection or Placebo","BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":38,"otherNames":36},[15],{"type":32,"name":33,"description":34,"armGroupLabels":40,"otherNames":36},[19],{"type":32,"name":33,"description":34,"armGroupLabels":42,"otherNames":36},[23],{"type":32,"name":33,"description":34,"armGroupLabels":44,"otherNames":36},[27],[46],{"name":47,"role":48,"phone":49,"phoneExt":36,"email":50},"Ying Zhang","CONTACT","+8618806137286","yingzhang@argobiopharma.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":36,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":36},"Argo Investigative Site","RECRUITING","Perth","Western Australia","Australia","AU",{"type":60,"coordinates":61},"Point",[62,63],115.8614,-31.95224,{"lat":63,"lon":62},{"type":66,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100640018","phase-1-a-phase-1-clinical-study-in-healthy-participants-100640018",false,"NCT07584876","A Phase 1 Clinical Study in Healthy Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants","Inclusion Criteria:\n\n* Must have given written informed consent and be able to comply with all study requirements\n* Males or females aged 18 to 65 years old, inclusive, at the time of informed consent\n* Body mass index (BMI) ≥18.0 and ≤32.0 kg\u002Fm2 and body weight ≥50.0 kg.\n* APTT, PT, INR, and FXI activity within the normal range at screening\n* Agree to avoid activities that can increase the risk of severe bleeding\n* Female participants must be non-pregnant\n* Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 360 days following administration of the study drug\n\nExclusion Criteria:\n\n* Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters\n* Any skin condition and\u002For tattoo\n* Hospitalization for any reason within 60 days prior to screening\n* History or presence of cancer\n* Any clinically significant acute condition\n* Systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg after at least 5 minutes resting\n* Clinical laboratory findings outside of range\n* Any liver function panel analyte value \\> 1.2 × upper limits of normal (ULN)\n* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody\n* Single 12-lead ECG with clinically significant abnormalities at screening or Day -1\n* Use of an investigational agent\n* .Used of prescription drugs\n* History or clinical evidence of alcohol substance abuse\n* History or clinical evidence of drug abuse\n* Positive test for alcohol or drugs of abuse at screening or Day -1\n* Donated or lost \\>200 mL of blood\n* .Any conditions which, in the opinion of the Investigator",true,"ALL","18 Years","65 Years",{"count":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"PHASE1",[85],"HV","2026-07-07",{"date":88,"type":89},"2026-07-09","ACTUAL",{"date":91,"type":89},"2026-05-29",{"date":93,"type":80},"2028-01-31",{"name":5,"class":6},1]