[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616375":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":26,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":26,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Beam Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BEAM-103 Drug Product","EXPERIMENTAL","BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm.",[13],"Drug: BEAM-103",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm.",[19],"Drug: Placebo Comparator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","BEAM-103","• BEAM-103 is a monoclonal antibody administered as a single intravenous dose",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Comparator","• The matching placebo comparator is administered as a single intravenous dose",[15],[32],{"facility":33,"status":34,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Clinical Study Site","RECRUITING","London","United Kingdom","UK",{"type":39,"coordinates":40},"Point",[41,42],-0.12574,51.50853,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Medical Information","CONTACT","+1 857-327-8641","clinicalinfo@beamtx.com",{"type":51,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100616375","phase-1-this-is-a-phase-1-randomized-single-blind-placebo-controlled-study-to-assess-the-safety-pharmacokinetics-pk-and-pharmacodynamics-pd-of-beam-103-in-healthy-subjects-100616375",false,"NCT07304791","This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of BEAM-103 in Healthy Subjects","A Randomized, Single-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BEAM-103 in Healthy Subjects","Inclusion Criteria:\n\n* Ages 18 to ≤55 years\n* Body mass index (BMI) of 18.5 to 25 kg\u002Fm2\n* Morning neutrophil count ≥2.6 × 109 cells\u002FL for Black\u002FAfrican American subjects or ≥3.5 ×109 cells\u002FL for Caucasian\u002FOther subjects\n* Baseline hemoglobin value of ≥14 g\u002FdL for males and ≥12 g\u002FdL for females\n* Baseline platelet count of \\>150 × 109\u002FL.\n* Subjects must be in general good health without significant medical conditions (based on physical exam, electrocardiogram (ECG), and laboratory test results with no clinically significant deviations), per the investigator's assessment\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the investigational medicinal product (IMP).\n* Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent is prohibited.\n* Positive serum pregnancy test or breastfeeding at screening (female participants).\n* Live virus vaccination within 4 weeks prior to signing informed consent.\n* Any severe or uncontrolled medical condition (eg. severe asthma or severe peanut allergy) that in the opinion of the investigator would put the subject at undue medical risk or impair the ability to interpret study results.",true,"ALL","18 Years","55 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. The main questions the study aims to answer are:\n\n* Safety and tolerability of BEAM-103\n* The pharmacokinetic (PK) profile and pharmacodynamic (PD) characteristics of EAM-103\n* The effect of BEAM-103 on hematologic parameters\n* To assess the immunogenicity of BEAM-103\n\nResearchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.\n\nSubjects will:\n\n* Be asked to participate in the study for a duration of 4-5 months total\n* Be asked to sign informed consent\n* Be assessed for eligibility\n* Provide medical and medication history\n* Receive a single intravenous infusion of BEAM-103 or placebo on study Day 1 according to their assigned cohort\n* Be followed up to 4 months after infusion",[71,72],"Healthy Subjects","Healthy Participant Study",[74,23],"ESCAPE","2025-12-12",{"date":77,"type":78},"2025-12-26","ACTUAL",{"date":80,"type":78},"2025-10-27",{"date":82,"type":65},"2026-05-29",{"name":5,"class":6},1]