[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653472":3},{"organization":4,"outcomesModule":7,"designInfo":99,"detailedDescription":36,"studyPopulation":36,"armGroups":111,"interventions":124,"overallOfficials":36,"centralContacts":36,"locations":133,"responsibleParty":154,"collaborators":36,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":36,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":36,"studyType":170,"phases":171,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":136,"whyStopped":36,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Arditus Pte Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Phase 1: Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest","Number and percentage of participants with treatment-emergent adverse events, serious adverse events, and adverse events of special interest will be summarised.","From first dose through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.",[14,18,22,25,28,31,34,37,39,41,43,46,49,52,55,59,63,66,69,72,75,78,81,84,86,90,93,96],{"measure":15,"description":16,"timeFrame":17},"Observed Body Weight and Change From Baseline","Observed body weight values and changes from baseline will be summarized.","Baseline and protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.",{"measure":19,"description":20,"timeFrame":21},"Number of Participants With Clinically Significant Changes From Baseline in Hematology Parameters","Hematology assessments include white blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils and basophils), red blood cell count and indices (mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration), hemoglobin, and platelet count. The number of participants with clinically significant changes from baseline in hematology parameters will be summarized. Clinical significance will be determined by the investigator.","At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.",{"measure":23,"description":24,"timeFrame":21},"Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Parameters","Serum chemistry assessments include creatinine, blood urea nitrogen, sodium, potassium, magnesium, phosphate, calcium, chloride, bicarbonate, fasting blood glucose, high-density lipoprotein, low-density lipoprotein, triglycerides, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total and direct bilirubin, thyroid-stimulating hormone, free thyroxine, lactate dehydrogenase, creatine kinase, C-reactive protein, and uric acid. The number of participants with clinically significant changes from baseline in serum chemistry parameters will be summarized. Clinical significance will be determined by the investigator.",{"measure":26,"description":27,"timeFrame":21},"Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Parameters","Urinalysis assessments include dipstick measurements of pH, protein, glucose, ketone, and blood, with reflex comprehensive urinalysis if abnormal as specified in the protocol. The number of participants with clinically significant changes from baseline in urinalysis parameters will be summarized. Clinical significance will be determined by the investigator.",{"measure":29,"description":30,"timeFrame":21},"Number of Participants With Clinically Significant Changes From Baseline in Coagulation Parameters","Coagulation assessments include prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer, and thrombin time. The number of participants with clinically significant changes from baseline in coagulation parameters will be summarized. Clinical significance will be determined by the investigator.",{"measure":32,"description":33,"timeFrame":21},"Observed Values and Change From Baseline in Systolic Blood Pressure","Observed systolic blood pressure values and changes from baseline will be summarised.",{"measure":35,"description":36,"timeFrame":21},"Observed Values and Change From Baseline in Diastolic Blood Pressure",null,{"measure":38,"description":36,"timeFrame":21},"Observed Values and Change From Baseline in Pulse Rate",{"measure":40,"description":36,"timeFrame":21},"Observed Values and Change From Baseline in Respiratory Rate",{"measure":42,"description":36,"timeFrame":21},"Observed Values and Change From Baseline in Body Temperature",{"measure":44,"description":45,"timeFrame":21},"Observed Values and Change From Baseline in PR Interval","Observed PR interval values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.",{"measure":47,"description":48,"timeFrame":21},"Observed Values and Change From Baseline in QRS Duration","Observed QRS duration values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.",{"measure":50,"description":51,"timeFrame":21},"Observed Values and Change From Baseline in QT Interval","Observed uncorrected QT interval values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.",{"measure":53,"description":54,"timeFrame":21},"Observed Values and Change From Baseline in QTcF Interval","Observed QT interval values corrected using Fridericia's formula and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.",{"measure":56,"description":57,"timeFrame":58},"Maximum Observed Serum Concentration of ARD001","Maximum observed serum concentration (Cmax) of ARD001 derived using noncompartmental analysis.","From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.",{"measure":60,"description":61,"timeFrame":62},"Time to Maximum Observed Serum Concentration of ARD001","Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of ARD001 derived using noncompartmental analysis.","Time of maximum observed serum concentration (Tmax) of ARD001 derived using noncompartmental analysis.",{"measure":64,"description":65,"timeFrame":58},"Area Under the Serum Concentration-Time Curve Extrapolated to Infinity","Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of ARD001 derived using noncompartmental analysis.",{"measure":67,"description":68,"timeFrame":58},"Mean Residence Time From Time Zero to Infinity of ARD001","Mean residence time from time zero to infinity (MRT0-inf) of ARD001 derived using noncompartmental analysis.",{"measure":70,"description":71,"timeFrame":58},"Lag Time Before the First Measurable Serum Concentration of ARD001","Time before the first measurable non-zero serum concentration (Tlag) of ARD001 derived using noncompartmental analysis.",{"measure":73,"description":74,"timeFrame":58},"Terminal Elimination Rate Constant of ARD001","Apparent terminal elimination rate constant (λz) of ARD001 derived from the terminal portion of the serum concentration-time profile using noncompartmental analysis.",{"measure":76,"description":77,"timeFrame":58},"Apparent Terminal Elimination Half-Life of ARD001","Apparent terminal elimination half-life (t1\u002F2) of ARD001 derived using noncompartmental analysis.",{"measure":79,"description":80,"timeFrame":58},"Apparent Volume of Distribution During the Terminal Phase of ARD001","Apparent volume of distribution during the terminal phase following subcutaneous administration (Vz\u002FF) of ARD001 derived using noncompartmental analysis.",{"measure":82,"description":83,"timeFrame":58},"Apparent Clearance of ARD001","Apparent clearance following subcutaneous administration (CL\u002FF) of ARD001 derived using noncompartmental analysis.",{"measure":85,"description":61,"timeFrame":58},"Area Under the Serum Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration",{"measure":87,"description":88,"timeFrame":89},"Number of Participants With Treatment-Emergent Anti-Drug Antibodies to ARD001","Number and percentage of participants with treatment-induced or treatment-boosted binding anti-drug antibodies to ARD001.","From baseline through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.",{"measure":91,"description":92,"timeFrame":12},"Time to First Detection of Anti-Drug Antibodies to ARD001","Time from first dose to the first scheduled post-baseline sample with a positive binding anti-drug antibody result.",{"measure":94,"description":95,"timeFrame":89},"Anti-Drug Antibody Titre to ARD001","Binding anti-drug antibody titre in participants with a positive anti-drug antibody result.",{"measure":97,"description":98,"timeFrame":89},"Persistence of Anti-Drug Antibodies to ARD001","Persistence of binding anti-drug antibodies to ARD001 based on positive results at protocol-specified post-dose assessment time points.",{"allocation":100,"interventionModel":101,"interventionModelDescription":102,"primaryPurpose":103,"observationalModel":36,"timePerspective":36,"maskingInfo":104},"RANDOMIZED","PARALLEL","Phase 1 comprises three sequentially single-ascending dose cohorts in healthy adults, with participants randomized within each cohort to ARD001 or Placebo. Phase 2 is planned as an open-label, multiple-dose study in adults with Hemophilia A and will be further defined in a protocol amendment before initiation.","TREATMENT",{"masking":105,"maskingDescription":106,"whoMasked":107},"TRIPLE","Phase 1 is blinded to participants, investigators and designated clinical care personnel. Designated unblinded pharmacy personnel will prepare and dispense study treatment. Phase 2 is planned to be open-label.",[108,109,110],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[112,118],{"label":113,"type":114,"description":115,"interventionNames":116},"Placebo","PLACEBO_COMPARATOR","In Phase 1, healthy adult participants randomized to placebo will receive a single subcutaneous dose of the corresponding placebo within one of the three sequential dose cohorts. No placebo treatment is planned for Phase 2",[117],"Other: Placebo",{"label":119,"type":120,"description":121,"interventionNames":122},"ARD001","EXPERIMENTAL","In Phase 1, healthy adult participants randomized to ARD001 will receive a single subcutaneous dose of 0.01, 0.1, or 0.3 mg\u002Fkg in one of three sequential ascending-dose cohorts. In Phase 2, adults with hemophilia A are planned to receive multiple subcutaneous doses of ARD001. The Phase 2 dose and regimen will be defined in a protocol amendment before Phase 2 initiation",[123],"Biological: ARD001",[125,129],{"type":126,"name":119,"description":127,"armGroupLabels":128,"otherNames":36},"BIOLOGICAL","ARD001 will be administered subcutaneously as a single dose of 0.01, 0.1, or 0.3 mg\u002Fkg in Phase 1. A multiple-dose regimen is planned for Phase 2 and will be specified in a protocol amendment before Phase 2 initiation",[119],{"type":130,"name":113,"description":131,"armGroupLabels":132,"otherNames":36},"OTHER","The corresponding placebo will be administered subcutaneously as a single dose in Phase 1",[113],[134],{"facility":135,"status":136,"city":137,"state":36,"zip":36,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"SingHealth Investigational Medicine Unit","RECRUITING","Singapore","SG",{"type":140,"coordinates":141},"Point",[142,143],103.85007,1.28967,{"lat":143,"lon":142},[146,151],{"name":147,"role":148,"phone":149,"phoneExt":36,"email":150},"Lavanya Lakshmi Jeeva","CONTACT","+65 63237544","lavanya.lakshmi.jeeva@singhealth.com.sg",{"name":152,"role":153,"phone":36,"phoneExt":36,"email":36},"Chuen Wen Tan, MB BCh BAO, FRCPath","PRINCIPAL_INVESTIGATOR",{"type":155,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100653472","phase-1-a-first-in-human-study-of-ard001-in-healthy-volunteers-and-people-with-hemophilia-a-100653472",false,"NCT07787091","A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A","A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study Investigating the Safety and Tolerability of ARD001 in Healthy Adult Subjects and a Phase 2 Open-Label, Multiple-Dose Study in Adult Subjects With Hemophilia A","Phase 1 Inclusion Criteria:\n\n* Healthy adults within the specified age and body-weight ranges\n* Able and willing to provide informed consent\n* Considered healthy based on medical history, physical examination, vital signs, electrocardiogram and laboratory assessments\n* Other essential criteria from the approved protocol\n\nPhase 1 Exclusion Criteria:\n\n* History of severe drug or food allergy, or known allergy to ARD001 or its components\n* Acute infection within 14 days before dosing or fever on the planned dosing day\n* Clinically significant cardiovascular, coagulation, hepatic, renal or other medical abnormality\n* Recent use of prohibited medications within the protocol-defined washout periods\n* Other major exclusions from the approved protocol",true,"MALE","21 Years","45 Years",{"count":168,"type":169},20,"ESTIMATED","INTERVENTIONAL",[172,173],"PHASE1","PHASE2","This study is evaluating ARD001, an investigational medicine being developed for the treatment of hemophilia A. In Phase 1, healthy adult participants will receive a single dose of ARD001 or placebo to assess its safety and tolerability, how it moves through the body, its effects on blood coagulation, and whether the body develops antibodies against it.\n\nIf the Phase 1 results support further study and the required regulatory and ethics approvals are obtained, Phase 2 will evaluate repeated doses of ARD001 in adults with hemophilia A. Phase 2 is not currently open for enrollment.\n\nThe study is designed to determine whether ARD001 can be administered with acceptable safety and to identify doses suitable for further clinical development.",[176,177],"Hemophilia A","Healthy Adult Participants",[119,179,180,176,181],"Single Ascending Dose","Healthy Volunteers","Coagulation","2026-08-21",{"date":184,"type":185},"2026-08-26","ACTUAL",{"date":187,"type":169},"2026-08",{"date":189,"type":169},"2027-03",{"name":5,"class":6},1]