[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640018":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":33,"studyPopulation":21,"armGroups":34,"interventions":57,"overallOfficials":21,"centralContacts":71,"locations":77,"responsibleParty":90,"collaborators":21,"id":92,"slug":21,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":21,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":21,"studyType":105,"phases":106,"briefSummary":96,"conditions":108,"keywords":21,"overallStatus":110,"whyStopped":21,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Argo Biopharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Primary endpoints","Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests","up to 24 hours",[14,18],{"measure":15,"description":16,"timeFrame":17},"Secondary endpoints","Assessment the PK parameters change\n\n* Maximum observed plasma concentration (Cmax)\n* Time to maximum plasma concentration (Tmax)\n* Terminal elimination half-life (t1\u002F2)\n* Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUClast)\n* Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)","up to 8 days",{"measure":15,"description":19,"timeFrame":20},"Assessment the PD parameters change\n\n* Change from baseline in the level of factor XI\n* Change from baseline in the level of activated partial thromboplastin time","up to 360days",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"QUADRUPLE",[29,30,31,32],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.",[35,41,45,49,53],{"label":36,"type":37,"description":38,"interventionNames":39},"Cohort 1","EXPERIMENTAL","BW-41012 (cohort 1, n=8)",[40],"Drug: BW-40202 injection or Placebo",{"label":42,"type":37,"description":43,"interventionNames":44},"Cohort 2","BW-41012 (cohort 2, n=8)",[40],{"label":46,"type":37,"description":47,"interventionNames":48},"Cohort 3","BW-41012 (cohort 3, n=8)",[40],{"label":50,"type":37,"description":51,"interventionNames":52},"Cohort 4","BW-41012 (cohort 4, n=8)",[40],{"label":54,"type":37,"description":55,"interventionNames":56},"Cohort 5","BW-41012 (cohort 5, n=8)",[40],[58,63,65,67,69],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":21},"DRUG","BW-40202 injection or Placebo","BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection",[36],{"type":59,"name":60,"description":61,"armGroupLabels":64,"otherNames":21},[42],{"type":59,"name":60,"description":61,"armGroupLabels":66,"otherNames":21},[46],{"type":59,"name":60,"description":61,"armGroupLabels":68,"otherNames":21},[50],{"type":59,"name":60,"description":61,"armGroupLabels":70,"otherNames":21},[54],[72],{"name":73,"role":74,"phone":75,"phoneExt":21,"email":76},"Ying Zhang","CONTACT","+8618806137286","yingzhang@argobiopharma.com",[78],{"facility":79,"status":21,"city":80,"state":81,"zip":21,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":21},"Argo Investigative Site","Perth","Western Australia","Australia","AU",{"type":85,"coordinates":86},"Point",[87,88],115.8614,-31.95224,{"lat":88,"lon":87},{"type":91,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","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":103,"type":104},40,"ESTIMATED","INTERVENTIONAL",[107],"PHASE1",[109],"HV","NOT_YET_RECRUITING","2026-05-07",{"date":113,"type":114},"2026-05-13","ACTUAL",{"date":116,"type":104},"2026-05-15",{"date":118,"type":104},"2028-01-31",{"name":5,"class":6},1]