[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484614":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":35,"responsibleParty":58,"collaborators":30,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":30,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: GSK1070806","EXPERIMENTAL","Participants in Part A will receive single dose of GSK1070806 intravenous (IV) infusion",[13],"Drug: GSK1070806",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: GSK1070806","Participants in Part B will receive single dose of GSK1070806 IV bolus",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Part A: Placebo","PLACEBO_COMPARATOR","Participants in Part A will receive single dose of placebo",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","GSK1070806","Participants will receive GSK1070806",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","Participants will receive placebo",[19],[36,49],{"facility":37,"status":30,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":30},"GSK Investigational Site","Cypress","California","90630","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.03729,33.81696,{"lat":47,"lon":46},{"facility":37,"status":30,"city":50,"state":51,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":30},"Las Vegas","Nevada","89113",{"type":44,"coordinates":54},[55,56],-115.13722,36.17497,{"lat":56,"lon":55},{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100484614","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamic-of-gsk1070806-after-a-single-intravenous-dose-in-healthy-male-and-female-caucasian-chinese-and-japanese-participants-aged-18-to-65-years-of-age-inclusive-100484614",false,"NCT05590338","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive","A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of a Single Intravenous Dose of GSK1070806 Administered to Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive","Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring \\[12-lead Electrocardiogram (ECGs)\\]\n* Between 18 and 65 years of age inclusive, at the time of signing the informed consent\n* Body weight within the range 45 - 100 kilograms (kg) and body mass index (BMI) within the range 18-32 kilogram\u002Fmeter square (kg\u002Fm\\^2) (inclusive)\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a woman of non-childbearing potential (WONCBP) OR\n* Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective \\[with a failure rate of less than 1 percent (\\\u003C1%) per year\\], with low user dependency\n* Capable of giving signed informed consent\n* Participants of Japanese ancestry are eligible based on meeting all of the following:\n* Healthy male and female participants born in Japan\n* Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents\n* Have lived outside Japan for less than 10 years at the time of screening\n* Chinese participants are eligible based on meeting all of the following:\n* Healthy male and female participants born in mainland China, Hong Kong, Macau or Taiwan\n* Descendants of four ethnic Chinese grandparents and two ethnic Chinese parents\n* Have lived outside mainland China, Hong Kong, Macau or Taiwan for less than 10 years at the time of screening\n* Participants of Caucasian\u002FEuropean ancestry are eligible if they self-identify to be of Caucasian\u002FEuropean ancestry and have 2 parents of Caucasian\u002FEuropean ancestry and 4 grandparents of Caucasian\u002FEuropean ancestry\n\nExclusion Criteria:\n\n* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, metabolic, musculoskeletal 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* Personal or family history of cardiomyopathy\n* Known varicella, herpes zoster, or other severe viral infection within 6 weeks of anticipated dosing on Day 1. Or history of recurrent herpes reactivation in the past 2 years\n* Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test\n* History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, anaphylaxis, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)\n* Lymphoma, leukemia, or any malignancy except for basal cell carcinomas of the skin that have been resected with no evidence of metastatic disease for 5 years\n* Alanine transaminase (ALT) greater than (\\>) 1.5x upper limit of normal (ULN)\n* Total bilirubin \\>1.5xULN (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%)\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or previous uncomplicated cholecystectomy more than 3 months ago)\n* Corrected QT using Bazett's formula (QTcB) (Bazett) or Corrected QT using Fridericia's formula (QTcF) (Fridericia) interval \\>450 milli second (msec)\n* History of Stevens Johnson Syndrome\n* Known immunodeficiency\n* Previous or current history of bleeding diathesis\n* Intended use of over the counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to dosing until final follow-up visit\n* Live vaccine(s) or plans to receive such vaccines within 2 months of dosing until final follow-up visit\n* Participation in the study would result in loss of blood or blood products in excess of 500 milli liter (mL) within 3 months\n* Current enrollment or past participation in any other clinical study involving an investigational study intervention or any other type of medical research within the last 30 days, 5 half-lives or twice the duration of the known pharmacological\u002Fbiological effect from the last dosing before dosing day in the current study\n* Coronavirus strain 19 (COVID-19) (severe acute respiratory syndrome - Coronavirus-2 (SARS CoV-2)):\n* Has had COVID-19 infection within 4 weeks of the initial screening visit\n* Positive coronavirus test (COVID-19: SARS-CoV-2 Polymerase chain reaction (PCR) or rapid antigen test) at initial screening\n* Signs and symptoms suggestive of COVID-19 (i.e., fever, cough, etc.) within 14 days of initial screening Known COVID-19-positive contacts within 14 days of initial Screening, at any time during the Screening Period, or within 14 days of dosing on Day 1\n* Active substance abuse or a history of substance abuse within 6 months prior to the initial Screening visit. Substance abuse including cannabis is also prohibited during the study",true,"ALL","18 Years","65 Years",{"count":72,"type":73},38,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","This study is divided into two parts:\n\nPart A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single intravenous (IV) infusion dose of GSK1070806 when administered to healthy participants of Japanese, Chinese and European\u002FCaucasian ancestry.\n\nPart B of the study is an open label single cohort arm to assess the safety, tolerability, PK and PD effect of a single IV bolus low dose of GSK1070806 in healthy participants of European\u002FCaucasian ancestry.",[79],"Dermatitis, Atopic",[81,82,27,83],"Immunoglobulin G1 (IgG1) antibody","Interleukin-18 (IL-18)","218841","COMPLETED","2024-08-12",{"date":87,"type":73},"2024-08-13",{"date":89,"type":73},"2022-11-04",{"date":91,"type":73},"2023-12-28",{"name":5,"class":6},2]