[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628248":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":28,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":28,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Clear Scientific, Inc.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).",[13,14,15],"Drug: Naloxone Hydrochloride","Drug: Fentanyl","Drug: Sterile Saline",{"label":17,"type":18,"description":19,"interventionNames":20},"Active","ACTIVE_COMPARATOR","Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).",[13,14,21],"Drug: CS-1103",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Naloxone Hydrochloride","Naloxone for intravenous administration",[17,9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Fentanyl","Fentanyl for intravenous administration",[17,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Sterile Saline","Sterile Saline for intravenous administration",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"CS-1103","CS-1103 for intravenous administration",[17],[42],{"name":43,"affiliation":5,"role":44},"Xinhua Li, Ph.D.","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Anna Del Rosario, B.S.","CONTACT","617-621-8500","adelrosario@clearsci.com",{"name":52,"role":48,"phone":49,"phoneExt":28,"email":53},"Piercen Oliver, Ph.D.","poliver@clearsci.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"California Clinical Trials Medical Group","RECRUITING","Glendale","California","91206","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-118.25508,34.14251,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":72,"phoneExt":28,"email":73},"Lev Gertsik, M.D.","888-228-7425","study.losangeles@parexel.com",{"type":75,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[77],{"name":78,"class":79},"National Institute on Drug Abuse (NIDA)","NIH","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":92,"type":93},16,"ESTIMATED","INTERVENTIONAL",[96],"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).",[99,100],"Fentanyl Overdose","Fentanyl Poisoning","2026-06-30",{"date":103,"type":104},"2026-07-01","ACTUAL",{"date":106,"type":104},"2026-05-28",{"date":108,"type":93},"2026-10",{"name":5,"class":6},1]