[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07712393":3,"trial-entities:NCT07712393":111,"trial-summary:NCT07712393":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":46,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":76,"locations":78,"central_contacts":100,"overall_officials":105,"references":109,"see_also_links":110},"NCT07712393","307918","A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283","Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection","RECRUITING","2027-04-26","2026-07","2026-07-29","2026-07-17","GlaxoSmithKline","INDUSTRY",false,"The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic \\[PK\\] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.",null,[19],"Asthma",[19,21,22,23,24,25],"GSK5784283","Pharmacokinetics","Safety","Tolerability","Healthy volunteers","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},24,"ESTIMATED",[34],{"type":35,"name":21,"description":36,"armGroupLabels":37},"DRUG","GSK5784283 will be administered.",[38,39],"GSK5784283 Reference Formulation","GSK5784283 Test Formulation",[41,44],{"measure":42,"timeFrame":43},"Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples","Pre-dose and up to 253 days post dose",{"measure":45,"timeFrame":43},"Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples",[47,50,53],{"measure":48,"timeFrame":49},"Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI)","Up to 253 days",{"measure":51,"timeFrame":52},"Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values","Baseline and up to 253 days",{"measure":54,"timeFrame":49},"Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283","ALL","18 Years","60 Years",true,{"inclusion":60,"exclusion":65,"raw_text":75},[61,62,63,64],"Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.","Body weight greater than or equal (\\>=) 50 kilogram (kg) (110 pounds \\[lbs\\]) and body mass index within the range 19 to 30 kilogram per meter square (kg\u002Fm\\^2) (inclusive).","A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.","Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.",[66,67,68,69,70,71,72,73,74],"Hypersensitivity- Participants with allergy\u002Fintolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously","History or presence of any clinically significant medical condition 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.","Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.","Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.","Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.","Current smokers (tobacco and\u002For marijuana) or former smokers with a smoking history \\>10 pack-years and participants using vaping products, including electronic cigarettes.","Regular alcohol consumption that exceeds the limits specified in the protocol","Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.","The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read \\>450 millisecond (msec).","Inclusion Criteria:\n\n* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.\n* Body weight greater than or equal (\\>=) 50 kilogram (kg) (110 pounds \\[lbs\\]) and body mass index within the range 19 to 30 kilogram per meter square (kg\u002Fm\\^2) (inclusive).\n* A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Hypersensitivity- Participants with allergy\u002Fintolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously\n* History or presence of any clinically significant medical condition 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* Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.\n* Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.\n* Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.\n* Current smokers (tobacco and\u002For marijuana) or former smokers with a smoking history \\>10 pack-years and participants using vaping products, including electronic cigarettes.\n* Regular alcohol consumption that exceeds the limits specified in the protocol\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.\n* The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read \\>450 millisecond (msec).",[77],"ADULT",[79],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":97},"GSK Investigational Site","Austin","Texas","78744","United States",[86,91,94],{"name":87,"role":88,"phone":89,"email":90},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":92,"role":88,"phone":93,"email":90},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":95,"role":96},"Sean Gilbey","PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},30.26715,-97.74306,[101,102],{"name":87,"role":88,"phone":89,"email":90},{"name":103,"role":88,"phone":104,"email":90},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[106],{"name":107,"affiliation":13,"role":108},"GSK Clinical Trials","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Healthy Volunteers",[],{"nct_id":4,"found":58,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 healthy adult participants.","completed","Study Comparing Two Formulations of GSK5784283 for Asthma","This study is comparing two different versions (formulations) of a medicine called GSK5784283. The main goal is to understand how your body processes each version of GSK5784283 over time, and to see if they are safe, well-tolerated, and work in the same way. We are looking for healthy adults between 18 and 60 years old who weigh at least 110 pounds and have a healthy body mass index. This study will enroll 24 participants. The success of the study will be measured by how much GSK5784283 is in your blood at different times after taking the medicine. The current status of this study is unclear.","Your blood levels of GSK5784283 will be measured for up to 253 days after you receive the medicine.",105,"Not specified in the trial record.","Not stated in the trial record.",[21],"v2"]