[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fentanyl-poisoning\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fentanyl-poisoning":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100628248","phase-2-a-phase-2-safety-tolerability-pk-and-efficacy-study-of-cs-1103-following-fentanyl-challenge-with-naloxone-blockade-100628248",false,"NCT07459166","A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade","Major Inclusion Criteria:\n\n1. Healthy participants aged 18 to 55 years, inclusive;\n2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;\n3. A body mass index between 18.0 to 30.0 kg\u002Fm2, inclusive, and a minimum body weight of 56 kg;\n4. Females must not be lactating and must have a negative pregnancy test during screening and admission.\n\nMajor Exclusion Criteria:\n\n1. Estimated glomerular filtration rate \\\u003C90 mL\u002Fmin\u002F1.73 m2;\n2. History of cardiovascular disease;\n3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).",[28,29],"Fentanyl Overdose","Fentanyl Poisoning","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2026-05-28",{"date":38,"type":22},"2026-10",{"name":40,"class":41},"Clear Scientific, Inc.","INDUSTRY"]