[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660328":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":66,"studyPopulation":11,"armGroups":67,"interventions":77,"overallOfficials":11,"centralContacts":90,"locations":96,"responsibleParty":111,"collaborators":11,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":11,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Adaxion Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of Treatment Emergent Adverse Events (TEAEs) of single and multiple doses of ADX-001 administered by subcutaneous and intravenous injection",null,"From first dose through Day 365 for participants receiving a single dose and through Day 505 for participants receiving multiple doses.",[14,17,20,22,24,26,28,30,32,34,36,38,40,43,45,47,49,51,53,55],{"measure":15,"description":11,"timeFrame":16},"PK Parameters peak concentration (Cmax) - SAD","Pre-dose on Day 1 through Day 365",{"measure":18,"description":11,"timeFrame":19},"PK Parameters peak concentration (Cmax) - MAD","Pre-dose on Day 1 through Day 87",{"measure":21,"description":11,"timeFrame":16},"Area under the concentration-time curve (AUC0-t) - SAD",{"measure":23,"description":11,"timeFrame":19},"Area under the concentration-time curve (AUC0-t) - MAD",{"measure":25,"description":11,"timeFrame":16},"Terminal elimination half-life (t1\u002F2) - SAD",{"measure":27,"description":11,"timeFrame":19},"Terminal elimination half-life (t1\u002F2) - MAD",{"measure":29,"description":11,"timeFrame":16},"Clearance (CL) - SAD",{"measure":31,"description":11,"timeFrame":19},"Clearance (CL) - MAD",{"measure":33,"description":11,"timeFrame":16},"Volume of distribution (Vz) - SAD",{"measure":35,"description":11,"timeFrame":19},"Volume of distribution (Vz) - MAD",{"measure":37,"description":11,"timeFrame":16},"Serum concentrations of free CD22L- SAD",{"measure":39,"description":11,"timeFrame":19},"Serum concentrations of free CD22L- MAD",{"measure":41,"description":11,"timeFrame":42},"Incidence of treatment-emergent anti-drug antibodies (ADA)","From Day 14 through Day 112 after a single dose, and through 56 days after the final dose following multiple doses",{"measure":44,"description":11,"timeFrame":42},"Maximum observed serum concentration (Cmax) of ADX-001 by ADA status",{"measure":46,"description":11,"timeFrame":42},"Minimum observed serum concentration (Cmin) of ADX-001 by ADA status",{"measure":48,"description":11,"timeFrame":42},"Area under the serum concentration-time curve (AUC0-last) of ADX-001 by ADA status",{"measure":50,"description":11,"timeFrame":42},"Area under the serum concentration-time curve over the dosing interval (AUCτ) of ADX-001 by ADA status",{"measure":52,"description":11,"timeFrame":42},"Clearance (CL) of ADX-001 by ADA status",{"measure":54,"description":11,"timeFrame":42},"Terminal elimination half-life (t½) of ADX-001 by ADA status",{"measure":56,"description":11,"timeFrame":42},"Incidence of treatment-emergent adverse events by ADA status",{"allocation":58,"interventionModel":59,"interventionModelDescription":11,"primaryPurpose":60,"observationalModel":11,"timePerspective":11,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":11,"whoMasked":63},"DOUBLE",[64,65],"PARTICIPANT","INVESTIGATOR","ADX-001 is a new investigational medicine being developed to treat inflammatory diseases, such as inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, and certain rheumatic diseases, such as psoriatic arthritis.\n\nThe purpose of this study is to evaluate the safety and tolerability of ADX-001 in healthy adult volunteers. The study will also examine how the body processes the medicine, how the medicine affects the immune system, and whether the body develops antibodies against the medicine. The results of this study will help determine appropriate doses and dosing schedules for future studies in patients with inflammatory diseases.",[68,74],{"label":69,"type":70,"description":11,"interventionNames":71},"SAD Cohort 1-5","EXPERIMENTAL",[72,73],"Drug: ADX-001","Drug: Placebo",{"label":75,"type":70,"description":11,"interventionNames":76},"MAD Cohort 6-9",[72,73],[78,83,86],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":11},"DRUG","ADX-001","ADX-001 administered as a single dose according to the assigned cohort and route of administration (SC or IV).",[69],{"type":79,"name":80,"description":84,"armGroupLabels":85,"otherNames":11},"ADX-001 administered every 4 weeks (Q4W) for a total of 4 doses according to the assigned cohort and route of administration (SC or IV).",[75],{"type":79,"name":87,"description":88,"armGroupLabels":89,"otherNames":11},"Placebo","Matching placebo administered by SC injection or IV infusion according to the route and dosing schedule of the assigned cohort.",[75,69],[91],{"name":92,"role":93,"phone":94,"phoneExt":11,"email":95},"Andrew Miller","CONTACT","+1-858-361-4192","amiller@adaxiontx.com",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":11},"CMAX Clinical Research","RECRUITING","Adelaide","South Australia","5000","Australia","AU",{"type":106,"coordinates":107},"Point",[108,109],138.59863,-34.92866,{"lat":109,"lon":108},{"type":112,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100660328","phase-1-a-study-of-single-and-multiple-subcutaneous-or-intravenous-doses-of-adx-001-in-healthy-adults-to-assess-safety-effects-and-immune-response-100660328",false,"NCT07876076","A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous and Intravenous ADX-001 in Healthy Adult Participants","Inclusion Criteria:\n\n* Provide informed consent - Be willing and able to sign a consent form after understanding the study and before any study-related procedures are performed.\n* Age - Be a healthy adult male or female aged 18 to 55 years.\n* Body weight and BMI - Have a Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm². Weigh more than 50 kg and less than 120 kg.\n* For women who can become pregnant - Have a negative pregnancy test before participating.\n* Use highly effective birth control during the study and for 15 months after the last study dose.\n\nExclusion Criteria:\n\nYou cannot participate in this study if any of the following apply to you:\n\n1. Medical Conditions\n\n   * You have a serious or ongoing health condition affecting the heart, lungs, liver, kidneys, digestive system, hormones, nervous system, immune system, or mental health.\n   * You have a history of severe allergic reactions, anaphylaxis, or are allergic to the study drug or its ingredients.\n2. Infections\n\n   * You test positive for HIV, hepatitis B, or hepatitis C.\n   * You have tuberculosis (TB), a history of TB, recent close contact with someone who has active TB, or a positive TB screening test.\n   * You test positive for COVID-19 before receiving the study drug.\n   * You have an active or long-term infection requiring treatment.\n   * You have needed antibiotics or other anti-infective treatment within the last month.\n   * You were hospitalized or required intravenous (IV) treatment for an infection within the last 3 months.\n   * You have a history of certain recurring infections, such as shingles (herpes zoster).\n   * You have a fever higher than 37.7°C during screening or within 7 days before dosing.\n   * In some cases, minor abnormalities may be accepted if the study doctor considers them not clinically important.\n\n4\\. Heart and Blood Pressure Problems 5. Previous Medications or Treatments\n\n* You have previously received medicines that target TNFα or IL-23.\n* You have received other biologic medicines within the last 6 months.\n* You have used medicines that significantly suppress the immune system within the required washout period.\n* You have recently used prescription or over-the-counter medications that could affect study results.\n* You received a live vaccine within the last 12 weeks or any other vaccine within the last 4 weeks.\n* You donated blood, plasma, or platelets too recently before joining the study.\n\n  6\\. Alcohol or Drug Use. 7. Pregnancy and Reproductive Considerations\n* You are pregnant, breastfeeding, or planning to become pregnant during the study period.\n* You are unwilling to use the required birth control methods.\n\n  8\\. Participation in Other Research Studies\n* You have recently participated in another clinical trial involving an investigational drug or device.\n* You have previously participated in this study.\n\n  9\\. Ability to Participate\n* You are unable to understand the study requirements or provide informed consent.\n* You are unable or unwilling to follow study procedures and visit schedules.\n\n  10\\. Conflict of Interest\n* You are an employee of the study sponsor or investigator, or an immediate family member of one.\n\n  11\\. Other Safety Concerns\n* The study doctor believes that participating could put your health at risk, prevent you from completing the study, or affect the reliability of the study results.",true,"ALL","18 Years","55 Years",{"count":125,"type":126},88,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of subcutaneous and intravenous ADX-001 in healthy adult participants",[132],"Healthy","2026-10-19",{"date":135,"type":136},"2026-10-21","ACTUAL",{"date":138,"type":136},"2026-10-20",{"date":140,"type":126},"2028-12-14",{"name":5,"class":6},1]