[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620038":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Alexion Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"ALXN2230","EXPERIMENTAL","Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.",[19],"Drug: ALXN2230",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Alexion Pharmaceuticals, Inc. (Sponsor)","CONTACT","1-855-752-2356","clinicaltrials@alexion.com",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Research Site","RECRUITING","London","NW10 7EW","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-0.12574,51.50853,{"lat":47,"lon":46},{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100620038","phase-1-safety-tolerability-pharmacokinetic-and-pharmacodynamic-study-of-alxn2230-in-healthy-participants-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":63,"type":64},48,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.",[70],"Healthy Adult Participants",[15,72,73,74,75,76,77,78,79],"Healthy Participants","Pharmacodynamics","Pharmacokinetics","PK","PD","Immunogenicity","First in Human","Single Ascending Dose","2026-04-06",{"date":82,"type":83},"2026-04-09","ACTUAL",{"date":85,"type":83},"2026-03-26",{"date":87,"type":64},"2026-12-23",{"name":5,"class":6},1]