[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650272":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"Trotana, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TRT-448","EXPERIMENTAL","TRT-448 dosed as oral capsules once (in single ascending dose cohorts) and daily for up to 28 days (in multiple ascending dose cohorts)",[13],"Drug: TRT-448",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo dosed as oral capsules once (in single ascending dose cohorts) and once daily for up to 28 days (in multiple ascending dose cohorts)",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Investigational drug modulates immune cells for the treatment of inflammatory disease",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Inert placebo utilized as control",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Clinical Operations","CONTACT","858-926-7304","clinops@trotana.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100650272","phase-1-phase-1-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-trt-448-in-healthy-adult-subjects-100650272",false,"NCT07745751","Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects","TRT-448-101","Inclusion Criteria:\n\n* Medically healthy , as determined by pre-study medical history, and without clinically significant abnormalities\n* Adult males and females, 18 to 55 years of age (inclusive) at screening\n* Body mass index (BMI) between 18 and 32 kg\u002Fm2 (inclusive) with body weight: ≥ 70 kg for the SAD 1 cohort; ≥ 50 kg for all other cohorts\n* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions\n\nExclusion Criteria:\n\n* History of anaphylaxis or other significant allergy which would interfere with the volunteer's ability to participate in the study, including severe Types I-IV hypersensitivity reactions, cytokine release syndrome, or allergic reactions to multiple drugs\n* History or presence of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal cholecystectomy, irritable bowel syndrome, inflammatory bowel disease, etc.), esophageal, endocrine, immunologic, autoimmune and\u002For inflammatory disease, dermatologic, psychiatric, or neurological disease\u002Fdisorder\n* History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.\n* Any history of malignant disease in the last 10 years, including leukemia, lymphoma or any significant hematology\u002Foncology disease.\n\nNote: Participants with curatively resected non-melanoma skin cancers \\>2 years prior to screening or curatively excised cervical carcinoma in situ \\> 5 years prior to screening are not excluded.\n\n* Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.\n* History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death or screening QTcF \\> 450 msec in males or \\> 470 msec in female) or a known arrhythmia (Note: asymptomatic first-degree heart block is not exclusionary).\n* Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, gallbladder, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.\n* Liver function test results elevated more than 1.3-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT).\n* Estimated glomerular filtration rate (eGFR) \\\u003C 80 mL\u002Fmin\u002F1.73m2 using the 2021 CKD-EPI creatinine equation.\n* Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.",true,"ALL","18 Years","55 Years",{"count":50,"type":51},144,"ESTIMATED","INTERVENTIONAL",[54],"PHASE1","Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects",[57],"Safety and Tolerability in Healthy Volunteers",[59,9,60],"Phase 1","Trotana","NOT_YET_RECRUITING","2026-08-04",{"date":64,"type":65},"2026-08-06","ACTUAL",{"date":67,"type":51},"2026-08-30",{"date":69,"type":51},"2027-05-30",{"name":5,"class":6}]