[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437954":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":21,"locations":22,"responsibleParty":36,"collaborators":21,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":21,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":21,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":21,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SAR443820","EXPERIMENTAL","Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods",[13],"Drug: RIPK1 inhibitor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","RIPK1 inhibitor","Capsule Oral",[9],[9],null,[23],{"facility":24,"status":21,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":21},"Investigational Site Number :8260001","Harrow","London, City of","HA1 3UJ","United Kingdom","UK",{"type":31,"coordinates":32},"Point",[33,34],-0.33208,51.57835,{"lat":34,"lon":33},{"type":37,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100437954","phase-1-single-ascending-dose-study-of-sar443820-in-healthy-adult-chinese-and-japanese-female-and-male-participants-100437954",false,"NCT04982991","Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants","A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.","Inclusion Criteria:\n\nEast Asian (Chinese and Japanese) male and\u002For female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent.\n\nChinese or Japanese ethnicity, according to the following criteria:\n\nChinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.\n\nJapanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.\n\nParticipants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.\n\nBody weight within 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, and body mass index (BMI) within the range 18.0 and 30.0 kg\u002Fm2, inclusive.\n\nExclusion Criteria:\n\nMedical history of any seizure.\n\nAny medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any live attenuated vaccine given within 3 months or any non-live vaccine given within 2 weeks before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n\nPositive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test.\n\nCurrent psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]), or a lifetime suicide attempt. A \"yes\" response to questions 4 or 5 on the Suicidal Ideation section, or a score of 4 or 5 on the Intensity of Ideation section of the baseline\u002Fscreening version of the C-SSRS at screening, or on the Since Last Visit version of the C-SSRS at baseline.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial",true,"ALL","20 Years","55 Years",{"count":50,"type":51},14,"ACTUAL","INTERVENTIONAL",[54],"PHASE1","Primary Objective:\n\nTo assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants.\n\nSecondary Objective:\n\nTo assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants",[57],"Multiple Sclerosis Healthy Subjects","COMPLETED","2022-04-21",{"date":61,"type":51},"2022-04-25",{"date":63,"type":51},"2021-08-05",{"date":65,"type":51},"2021-10-11",{"name":5,"class":6},1]