[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Adaxion Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"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",[28],"Healthy","RECRUITING","2026-10-19",{"date":32,"type":33},"2026-10-21","ACTUAL",{"date":35,"type":33},"2026-10-20",{"date":37,"type":22},"2028-12-14",{"name":39,"class":40},"Adaxion Therapeutics","INDUSTRY",""]