[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100104665":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":33,"responsibleParty":47,"collaborators":32,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":32,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":32,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":70,"whyStopped":32,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Alvine Pharmaceuticals Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A","PLACEBO_COMPARATOR","Placebo",[13],"Drug: 4 dose levels of ALV003",{"label":15,"type":16,"description":17,"interventionNames":18},"B","ACTIVE_COMPARATOR","Active study Drug: ALV003",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","4 dose levels of ALV003","4 dose levels of ALV003 vs placebo",[9,15],[26],"ALV003 and ALV003 placebo equivalent",[28],{"name":29,"affiliation":30,"role":31},"Vijaya Pratha, MD","Clinical Applications Laboratory Inc.","PRINCIPAL_INVESTIGATOR",null,[34],{"facility":35,"status":32,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":32},"Clinical Applications Laboratories Inc.","San Diego","California","92103","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-117.16472,32.71571,{"lat":45,"lon":44},{"type":32,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":48,"oldOrganization":35},"Vijaya Pratha, M.D., Principal Investigator","100104665","phase-1-a-phase-1-study-of-the-safety-and-tolerability-of-alv003-in-healthy-adult-volunteers-and-subjects-with-well-controlled-celiac-disease-100104665",false,"NCT00626184","A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease","A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease","INCLUSION\n\n* Health Status\n\n  1. Healthy volunteers must be in good health\n  2. Celiac Disease must be well controlled and in good health\n* Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.\n* Body Mass Index (BMI) of \\\u003C 30 kg\u002Fm2,\n\nEXCLUSION\n\n* A positive urine test for alcohol or illegal drugs at screening.\n* The subject has received an experimental drug within 30 days of the present study.\n* History of substance abuse, within the last 5 years\n* Clinically significant abnormal lab values, as determined by the PI\n* Alcohol consumption of \\> 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.\n* history of any medically significant condition considered by the PI to adversely affect participation in the trial",true,"ALL","18 Years","45 Years",{"count":61,"type":62},28,"ACTUAL","INTERVENTIONAL",[65],"PHASE1","To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease",[68],"Celiac Disease",[68],"COMPLETED","2009-08-17",{"date":73,"type":74},"2009-08-18","ESTIMATED",{"date":76,"type":32},"2008-02",{"date":78,"type":62},"2008-07",{"name":5,"class":6},1]