[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620038":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":33,"studyPopulation":11,"armGroups":34,"interventions":47,"overallOfficials":11,"centralContacts":55,"locations":61,"responsibleParty":75,"collaborators":11,"id":77,"slug":11,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Alexion Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)",null,"Day 1 up to Day 113",[14,16,18,20],{"measure":15,"description":11,"timeFrame":12},"Maximum Observed Serum Concentration (Cmax) of ALXN2230",{"measure":17,"description":11,"timeFrame":12},"Time to Cmax (Tmax) of ALXN2230",{"measure":19,"description":11,"timeFrame":12},"Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230",{"measure":21,"description":11,"timeFrame":12},"Serum Concentration of Biomarkers",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":27,"maskingDescription":11,"whoMasked":28},"QUADRUPLE",[29,30,31,32],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Part A of this study is expected to enroll approximately 40 participants (30 on ALXN2230 and 10 on placebo) across 5 cohorts and Part B is expected to enroll approximately 8 participants (6 on ALXN2230 and 2 on placebo) in 1 cohort.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Placebo","PLACEBO_COMPARATOR","Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.",[40],"Drug: Placebo",{"label":42,"type":43,"description":44,"interventionNames":45},"ALXN2230","EXPERIMENTAL","Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.",[46],"Drug: ALXN2230",[48,52],{"type":49,"name":42,"description":50,"armGroupLabels":51,"otherNames":11},"DRUG","Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.",[42],{"type":49,"name":36,"description":53,"armGroupLabels":54,"otherNames":11},"Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.",[36],[56],{"name":57,"role":58,"phone":59,"phoneExt":11,"email":60},"Alexion Pharmaceuticals, Inc. (Sponsor)","CONTACT","1-855-752-2356","clinicaltrials@alexion.com",[62],{"facility":63,"status":64,"city":65,"state":11,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":11},"Research Site","RECRUITING","London","NW10 7EW","United Kingdom","UK",{"type":70,"coordinates":71},"Point",[72,73],-0.12574,51.50853,{"lat":73,"lon":72},{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620038",false,"NCT07352423","Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN2230 in Healthy Adult Participants","Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Baseline immunoglobulin G (IgG) concentrations ≥ 1000 milligrams per deciliter (mg\u002FdL) and ≤ 1600 mg\u002FdL at Screening.\n* Antibody titers for Tetanus toxoid (≥ 0.1 International Units per milliliter (IU\u002FmL)) at Screening.\n* Nonsmokers and not using any nicotine-containing products. A nonsmoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.\n* BMI within the range 18 to 32 kilograms per square meter (kg\u002Fm2), inclusive; with body weight ≥ 50 kilograms (kg).\n\nExclusion Criteria:\n\n* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.\n* Abnormal blood pressure (BP) (resting BP not to exceed 140\u002F80 mmHg and no less than 90\u002F60 mmHg).\n* Participants who have history of allergy or hypersensitivity to excipients in ALXN2230.\n* History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day 1.\n* Pregnant or breastfeeding females are excluded from the clinical study.\n* Participants with known clinically relevant immunological disorders.\n* Lymphoma, leukemia, breast cancer or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 5 years.\n* ALT \\> 1.0 × upper limit of normal (ULN)\n* TBIL \\> 1.0 × ULN\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with exception for Gilbert's syndrome).\n* QTc \\> 450 millisecond (msec) for male participants or \\> 470 msec for female participants.\n* Significant blood loss (including blood donation \\[\\> 500 mL\\]) or had a transfusion of any blood product within 12 weeks prior to dosing or plan 1 within 4 weeks after the end of the study.\n\nAdditional inclusion\u002Fexclusion criteria may apply, per protocol.",true,"ALL","18 Years","65 Years",{"count":88,"type":89},48,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.",[95],"Healthy Adult Participants",[42,97,98,99,100,101,102,103,104],"Healthy Participants","Pharmacodynamics","Pharmacokinetics","PK","PD","Immunogenicity","First in Human","Single Ascending Dose","2026-04-06",{"date":107,"type":108},"2026-04-09","ACTUAL",{"date":110,"type":108},"2026-03-26",{"date":112,"type":89},"2026-12-23",{"name":5,"class":6},1]