[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Autotelicbio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4},"100639668","phase-1-a-study-to-compare-the-pharmacokinetics-and-safety-of-the-atb-u101-and-atb-u1011atb-u1012-and-atb-1011atb-1012-in-healthy-caucasian-participants-100639668",false,"NCT07590466","A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants","A Phase 1, Open-Label, Randomized, Crossover, Single-dose Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants","Inclusion Criteria:\n\n* Healthy Caucasian adult volunteers aged between 19 and 64 years (inclusive) at the time of screening\n* Caucasian volunteers: Individuals whose parents and grandparents are European, North American, or Middle Eastern, who were born in Europe, North America, or Western Asia, and whose cumulative residence in countries outside those regions since birth is less than 10 years\n* Individuals whose weight at screening is between 50.0 kg and 97.0 kg and whose body mass index (BMI) is between 18.0 kg\u002Fm2 and 30.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Subjects who test positive on serologic tests (hepatitis B, hepatitis C, human immunodeficiency virus \\[HIV\\], or syphilis)",true,"ALL","19 Years","64 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this Phase 1 clinical trial is to compare the pharmacokinetics and safety of a fixed-dose combination tablet (ATB-U101) versus co-administration of its individual components in healthy Caucasian adult volunteers. The main questions it aims to answer are:\n\n* Is the Cmax of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens?\n* Is the AUClast of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens?\n\nResearchers will compare ATB-U101 (fixed-dose combination, 40 mg\u002F10 mg) against two reference co-administrations - ATB-1011+ATB-1012 (Korean-approved Olmetec + Forxiga) and ATB-U1011+ATB-U1012 (US-approved Benicar + Farxiga) - to see if the 90% confidence intervals of the geometric mean ratios for the primary PK parameters fall within the bioequivalence range of 80.00-125.00%.\n\nParticipants will:\n\n* Be admitted to the clinical trial center three times (Days 1, 8, and 15), each separated by a 7-day washout period\n* Receive a single oral dose of one assigned treatment per period under fasting conditions (minimum 10 hours) with 240 mL of water, in a randomized crossover sequence\n* Have blood samples collected at up to 18 timepoints per period (up to 48 hours post-dose) for PK analysis\n* Undergo safety assessments including vital signs, ECG, physical examination, and laboratory tests throughout the study, with a final follow-up visit around Day 21-24",[28,29],"Diabete Type 2","Hypertension","NOT_YET_RECRUITING","2026-05-12",{"date":33,"type":34},"2026-05-15","ACTUAL",{"date":36,"type":22},"2026-05-18",{"date":38,"type":22},"2026-08-31",{"name":40,"class":41},"Autotelicbio","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100587833","phase-1-evaluation-of-safety-and-tolerability-of-atb-320-in-participants-with-progressive-or-metastatic-solid-tumors-100587833","NCT06933524","Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of ATB-320 in Patients With Progressive or Metastatic Solid Tumors","ATB-320-001A","Inclusion Criteria:\n\n1. Adult (18 years or older) at the time of screening\n2. Histologically confirmed solid tumor\n3. Participants must have failed standard therapy or cannot tolerate standard therapy.\n4. Participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n6. Life expectancy of ≥ 12 weeks\n\nExclusion Criteria:\n\n1. Has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter)\n2. Has received immunotherapy within 2 weeks of the first planned dose of investigational product\n3. Major surgery within 4 weeks prior to the first planned dose of the investigational product\n4. Previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma\u002Fsquamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study.\n5. Current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product)\n6. Has received prior radiotherapy within 2 weeks of the first planned dose. Participants who have received palliative radiotherapy for non-central nervous system (CNS) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis)\n7. History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs","18 Years",{"count":52,"type":22},24,[25],"The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors",[56],"Solid Tumors","2025-09-30",{"date":59,"type":34},"2025-10-01",{"date":61,"type":22},"2025-12-01",{"date":63,"type":22},"2028-12-01",{"name":40,"class":41},""]