[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659274":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":35,"studyPopulation":25,"armGroups":36,"interventions":55,"overallOfficials":25,"centralContacts":64,"locations":70,"responsibleParty":92,"collaborators":25,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":25,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":25,"overallStatus":115,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Ursa Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety and tolerability of single ascending doses of VELA-101","Incidence, severity, and relationship of treatment-emergent adverse events and changes from baseline in vital signs, electrocardiogram parameters, and clinical laboratory parameters","Day 180",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"To characterise the plasma pharmacokinetics of single ascending doses of VELA-101","Plasma concentrations of VELA-101","Day 1 to Day 3",{"measure":19,"description":20,"timeFrame":17},"To characterise the urine pharmacokinetics of single ascending doses of VELA-101","Urine concentrations of VELA-101",{"measure":22,"description":23,"timeFrame":24},"To evaluate the effect of VELA-101 on lipid parameters following a single SC administration","Change from baseline in blood lipid parameters","Up to Day 360",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":32},"DOUBLE",[33,34],"PARTICIPANT","INVESTIGATOR","The study consists of 2 sequential parts:\n\n* Part A: Single-ascending doses in healthy participants\n* Part B: Single-ascending doses in participants with hyperlipidemia",[37,43,48,52],{"label":38,"type":39,"description":40,"interventionNames":41},"VELA-101 in Healthy Adult Participants","EXPERIMENTAL","Part A",[42],"Drug: VELA-101",{"label":44,"type":45,"description":40,"interventionNames":46},"In Healthy Adults","PLACEBO_COMPARATOR",[47],"Drug: Placebo",{"label":49,"type":39,"description":50,"interventionNames":51},"VELA-101 in Participants with Hyperlipidemia","Part B",[42],{"label":53,"type":45,"description":50,"interventionNames":54},"In Participants with Hyperlipidemia",[47],[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"DRUG","VELA-101","subcutaneous injection",[38,49],{"type":57,"name":62,"description":59,"armGroupLabels":63,"otherNames":25},"Placebo",[44,53],[65],{"name":66,"role":67,"phone":68,"phoneExt":25,"email":69},"Study Director","CONTACT","617-798-2120","clinicaltrials@ursameds.com",[71,83],{"facility":72,"status":25,"city":73,"state":74,"zip":25,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":25},"University of Sunshine Coast","Morayfield","Queensland","Australia","AU",{"type":78,"coordinates":79},"Point",[80,81],152.94907,-27.10876,{"lat":81,"lon":80},{"facility":84,"status":25,"city":85,"state":86,"zip":25,"country":75,"countryCode":76,"cosmosGeoPoint":87,"geoPoint":91,"contacts":25},"Linear Clinical Research","Nedlands","Western Australia",{"type":78,"coordinates":88},[89,90],115.8073,-31.98184,{"lat":90,"lon":89},{"type":93,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100659274","phase-1-a-phase-1-study-of-vela-101-in-adult-participants-100659274",false,"NCT07864311","A Phase 1 Study of VELA-101 in Adult Participants","A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VELA-101 in Adult Participants","Key Inclusion Criteria (All Parts):\n\n* Participants must be adults able to understand the study, provide written informed consent, and comply with study procedures.\n* Age: Part A: 18-55 years; Part B: 18-65 years\n* BMI and body weight: Part A: BMI 18.0-30.0 kg\u002Fm²; Part B: BMI 18.0-35.0 kg\u002Fm²\n* Considered medically healthy based on medical history and screening assessments.\n* Male and Female participants must agree to contraception requirements.\n\nKey Inclusion Criteria (Part B):\n\n\\- Elevated LDL-C and Lipoprotein(a)\n\nKey Exclusion Criteria (All Parts):\n\n* Known familial hypercholesterolemia or severe hypertriglyceridemia.\n* Clinically significant cardiovascular, liver, kidney, immune, or other medical disease.\n* Positive screening for HIV, hepatitis B, or hepatitis C.\n* Current significant infection, substance misuse, or other condition that could interfere with study participation.\n\nKey Exclusion Criteria (Part B):\n\n* Uncontrolled type 2 diabetes.\n* Recent changes in lipid-lowering therapy.\n* History of significant cardiovascular disease, including myocardial infarction, stroke, heart failure, significant arrhythmia, or uncontrolled hypertension.",true,"ALL","18 Years","65 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","This is a first-in-human (FIH), multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VELA-101, following single-ascending doses via subcutaneous (SC) administration.",[113,114],"Healthy Participants","Hyperlipidemia","NOT_YET_RECRUITING","2026-10-02",{"date":118,"type":119},"2026-10-07","ACTUAL",{"date":121,"type":107},"2026-11",{"date":123,"type":107},"2027-09",{"name":5,"class":6},2]