[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Basilea Pharmaceutica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":154},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,76,107,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100587202","phase-3-a-phase-3-efficacy-and-safety-study-of-fosmanogepix-for-the-treatment-of-adult-patients-with-invasive-mold-infections-100587202",false,"NCT06925321","A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.","An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds","Main Inclusion Criteria:\n\n1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC\u002FMSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.\n2. Patient's condition allows for appropriate infection source control measures.\n\nMain Exclusion Critera:\n\n1. Refractory hematologic malignancy.\n2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.\n3. Coronavirus disease 2019 (COVID-19) associated mucormycosis.\n4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.\n5. Patients with a Karnofsky Performance Status \\\u003C 20 at Screening.\n6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.\n7. Patients with known human immunodeficiency virus infection.\n8. Ongoing neurological disorders.\n9. Patients receiving hospice\u002Fcomfort care only.\n10. Other medical or psychiatric condition.\n11. Current use of any prohibited concomitant medication(s).\n12. Current\u002F previous administration of an investigational drug within 30 days.\n13. Prior enrollment in this or any previous study of fosmanogepix.\n14. Moderate or severe hepatic impairment.\n15. Patient who is pregnant or lactating.\n16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.","ALL","18 Years",{"count":19,"type":20},234,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.\n\nThe patient will be assigned to one of two treatment cohorts:\n\nCohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.\n\nCohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug\n\nThe primary aim is to compare the all cause mortality with a fixed threshold at Day 42.",[26],"Invasive Mold Infections",[28,29,30,31,32,33,34,35,36,37],"Fungal infection","Antifungal","Mold infection","Rare molds","Multidrug resistant mold","Aspergillus spp.","Fusarium spp.","Lomentospora prolificans","Mucorales fungi","Scedosporium spp.","RECRUITING","2026-06-12",{"date":41,"type":42},"2026-06-15","ACTUAL",{"date":44,"type":42},"2025-08-26",{"date":46,"type":20},"2028-02",{"name":48,"class":49},"Basilea Pharmaceutica","INDUSTRY",68,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100471667","phase-3-a-phase-3-efficacy-and-safety-study-of-fosmanogepix-for-the-treatment-of-adult-participants-with-candidemia-andor-invasive-candidiasis-100471667","NCT05421858","A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and\u002For Invasive Candidiasis.","An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and\u002For Invasive Candidiasis","Inclusion Criteria:\n\n1. Patients ≥ 18 years (or the minimum country-specific age of consent if \\> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself\u002Fherself, a legally authorized representative must provide informed consent on his\u002Fher behalf.\n2. Diagnosis of candidemia and\u002For invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia\u002Finvasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.\n3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.\n\nExclusion Criteria:\n\n1. Existing infection\n\n   1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.\n   2. Inappropriate fungal infection source control.\n   3. Diagnosis of certain deep-seated Candida infections.\n2. Life expectancy of \\\u003C 72 hours in the opinion of the investigator.\n3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.\n4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia \u002F invasive candidiasis are not exclusionary).\n5. Patients with known human immunodeficiency virus infection, who have CD4+ count \\\u003C 200\u002Fmm3 or viral load \\> 400 copies\u002FmL), or who have had an active opportunistic infection within 6 months prior to Screening.\n6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.\n7. Current use of any prohibited concomitant medications or those unwilling\u002Funable to use a permitted concomitant medication.\n8. Received \\> 2 days (\\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and\u002For invasive candidiasis (e.g., \\> 2 doses of a once daily antifungal agent or \\> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).\n9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).\n10. Prior participation in this or any previous study of fosmanogepix.\n11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \\> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.\n12. Female patient is pregnant or lactating.\n13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.\n14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":59,"type":20},450,[23],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and\u002For invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.\n\nThe study is seeking patients who have a diagnosis of candidemia and\u002For invasive candidiasis.\n\nTwo-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.\n\nFosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.\n\nThe treatment effect in patients receiving fosmanogepix to those receiving caspofungin\u002F fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin\u002F fluconazole with a noninferiority margin of 15%.\n\nThe duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.",[63,64],"Candidemia","Candidiasis, Invasive",[28,66,67,68],"Candida","Anti-fungal","Yeast",{"date":41,"type":42},{"date":71,"type":42},"2024-12-11",{"date":73,"type":20},"2028-01-30",{"name":48,"class":49},143,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100631400","phase-1-a-phase-i-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-bal2420-in-healthy-adult-subjects-100631400","NCT07500181","A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects","A First-in-Human, Randomized, Dose-escalation, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of BAL2420 Administered to Healthy Adult Subjects","Inclusion Criteria:\n\n* Body mass index: 18.0 to 30.0 kg\u002Fm2, inclusive, at screening\n* Total body weight: \\> 50 kg at screening\n\nExclusion Criteria:\n\n* Any uncontrolled or active major systemic disease,\n* Active infection\n* Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments.\n* Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities\n* History of risk factors for QT prolongation or Torsades de Pointes\n* QTcF (Fridericia's corrected QT interval) \\> 450 msec (males) and \\> 470 msec (females) at screening.\n* Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site.\n* Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site.\n* History of relevant drug and\u002For food allergies, particularly to antibiotics.\n* History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration.\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening.\n* Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.\n* Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.",true,"55 Years",{"count":86,"type":20},136,[88],"PHASE1","BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.",[91],"Healthy",[93,94,95,96,97],"BAL2420","BAL0302420","Antibacterial agent","Pharmacokinetics","Healthy adults","2026-03-24",{"date":100,"type":42},"2026-03-30",{"date":102,"type":42},"2026-03-04",{"date":104,"type":20},"2027-06",{"name":48,"class":49},1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":106},"100572469","phase-1-safety-and-pk-of-ceftibuten-ledaborbactam-etzadroxil-fixed-dose-combination-100572469","NCT06733675","Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination","A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil","Inclusion Criteria:\n\n* Healthy adult male or female, between 18 and 55 years of age\n* Body mass index ≥ 18 and ≤ 32 kg\u002Fm2\n* Laboratory values meeting defined laboratory ranges\n* Males or non-pregnant, non-lactating females\n\nExclusion Criteria:\n\n* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug\n* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant\n* Positive alcohol, drug or tobacco use\u002Ftest",{"count":115,"type":20},46,[88],"This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.",[119,96,120,121,122],"Healthy Volunteer","Safety","Drug-Drug Interaction (DDI)","FDC",[124,125,126],"Healthy Volunteers","Ceftibuten","Ledaborbactam etzadroxil","2025-12-17",{"date":129,"type":42},"2025-12-18",{"date":131,"type":42},"2025-01-07",{"date":133,"type":20},"2026-06-30",{"name":48,"class":49},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":141,"conditions":144,"keywords":146,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":153,"locationsCount":4},"100549370","expanded-access-to-fosmanogepix-for-patients-with-serious-or-life-threatening-invasive-fungal-infections-100549370","NCT06433128","Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections","Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options","The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.","12 Years","EXPANDED_ACCESS",[145],"Invasive Fungal Infections",[28,66,67,68,147,148],"Mold","Rare mold","AVAILABLE","2025-07-23",{"date":152,"type":42},"2025-07-24",{"name":48,"class":49},""]