[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aptabio Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,74],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618365","phase-1-a-phase-1-study-of-abf-101-in-single--and-multiple-ascending-doses-100618365",false,"NCT07330674","A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses","A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101","Inclusion Criteria:\n\n* Part A and B\n\n  1. Healthy participants, aged between 18 and 50 years\n  2. Provides written, signed, informed consent prior to selection\n  3. BMI of ≥ 18.0 and \\\u003C 32.0 kg\u002Fm2, and body weight between 50 kg and 115 kg, inclusive.\n  4. Vital signs: normal pulse rate and blood pressure.\n  5. Nonsmoker\n  6. Must be willing to abstain from caffeine and alcohol\n  7. Must be willing to avoid strenuous activity\n* Part C\n\n  1. Confirmed diagnosis of AMD\n  2. Male or female ≥50 years of age\n  3. Adequate visual acuity in the non-study eye\n\nExclusion Criteria:\n\n* Part A and B\n\n  1. Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease\n  2. Any significant abnormalities detected during ocular examination,\n  3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician\n  4. Any drug intake (except paracetamol or contraceptives)\n  5. History or presence alcohol abuse\n  6. History or presence of drug abuse\n  7. Positive HBsAg or anti-HCV antibody, or positive results for HIV\n  8. Blood donation, significant blood loss, or has received a transfusion of any blood or blood products\n  9. Female participants who are breastfeeding.\n  10. Female participants must not be pregnant or at risk to become pregnant during the study. Male and female participants must agree to use highly effective contraception\n  11. Participant who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language barrier or poor mental development\n\nPart C\n\n1. Evidence of CNV due to any cause other than AMD\n2. History of vitreoretinal surgery\n3. Significant ocular diseases that may interfere with the study\n4. Significantly impaired renal or hepatic function\n5. Use of immunosuppressive drugs\n6. Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy\n7. History of severe drug allergies or drug hypersensitivity syndrome\n8. Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern.\n9. Severe cardiac disease.\n10. QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities\n11. Stroke or transient ischemic attack\n12. Any major surgical procedure w\n13. Serious active infection, other serious medical condition or any other condition that would impair the ability of the participant to administer the investigational drug or to adhere to the study protocol requirements\n14. Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study",true,"ALL","18 Years","50 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1 study to evaluate the safety, tolerability, PK, and PD of ABF-101 in healthy participants and participants with age-related macular degeneration (AMD).",[28,29],"Age Related Macular Degeneration (ARMD)","AMD - Age-Related Macular Degeneration",[31,32,33],"ABF-101","AMD","NOX","RECRUITING","2026-02-04",{"date":37,"type":38},"2026-02-06","ACTUAL",{"date":40,"type":22},"2026-02",{"date":42,"type":22},"2027-12",{"name":44,"class":45},"Aptabio Therapeutics, Inc.","INDIV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100602431","phase-1-a-phase-1-study-of-apx-343a-as-monotherapy-or-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100602431","NCT07123415","A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.\n2. Willing and able to give informed consent and to comply with the requirements of the study.\n3. Histologically or cytologically confirmed advanced solid tumor.\n4. Life expectancy of at least 3 months in the judgment of the investigator.\n5. ECOG performance status of 0 to 1 during the screening period.\n6. Measurable disease per RECIST v1.1 as assessed by the site investigator\u002Fradiology.\n7. Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.\n8. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline.\n9. Adequate organ function as defined in the following table.\n10. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to the first dose of study drug.\n11. Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n12. Male subjects must agree to use an adequate method of contraception.\n13. Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding.\n\nExclusion Criteria:\n\n1. Received any prior immunotherapy.\n2. Received prior systemic anticancer therapy including investigational agents.\n3. Received prior radiotherapy.\n4. Received a live or live-attenuated vaccine .\n5. Has received an investigational agent.\n6. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n7. Known additional malignancy.\n8. Known active CNS metastases and\u002For carcinomatous meningitis.\n9. Active autoimmune disease.\n10. History of (noninfectious) pneumonitis\u002Finterstitial lung disease.\n11. Active, uncontrolled infection requiring systemic therapy.\n12. Unable to swallow study drug or disease that interfere with proper absorption of study drug.\n13. Significant cardiovascular disease.\n14. Cerebrovascular accident.\n15. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study.\n16. History of severe hypersensitivity to pembrolizumab and\u002For any of its excipients.\n17. History of hypersensitivity to APX-343A and\u002For any of its excipients.\n18. History of allogeneic tissue\u002Fsolid organ transplant.\n19. History of HIV infection or HIV positive at screening.\n20. Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.","19 Years",{"count":56,"type":22},110,[25],"This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.",[60,61],"Advanced Solid Cancer","Advanced Solid Tumor (Phase 1)",[60,61,63,64,65,33],"APX-343A","ICI","CAF","2025-11-17",{"date":68,"type":38},"2025-11-19",{"date":70,"type":38},"2025-10-24",{"date":72,"type":22},"2028-12",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100590029","phase-2-efficacy-and-safety-study-of-isuzinaxib-in-subjects-with-dkd-100590029","NCT06962098","Efficacy and Safety Study of Isuzinaxib in Subjects With DKD","A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease","PROMISS-DKD","Inclusion Criteria:\n\n1. Male\u002Ffemale subject aged ≥19 years inclusive at the time of informed consent.\n2. Clinical diagnosis of type 2 diabetes and DKD.\n3. 18.5 kg\u002Fm² \\\u003C body mass index \\\u003C 35 kg\u002Fm².\n4. Stable UACR values prior to screening visit.\n5. UACR between 200 and 3000 mg\u002Fg.\n6. Hemoglobin A1c ≤10% at Screening Visit.\n7. Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication.\n8. Subject who has been on stable anti-hyperglycemic prior to screening.\n9. Females of childbearing potential\u002Fsexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control.\n10. Willing to be under dietary management for diabetes.\n11. Willing to comply with all study procedures and availability for the duration of the study.\n12. Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures.\n\nExclusion Criteria:\n\n1. History of type 1 diabetes mellitus or gestational diabetes.\n2. Subject's renal impairment and\u002For albuminuria is considered to be of origin other than DKD.\n3. History of renal transplant and\u002For plan to undergo a renal transplant during the study.\n4. History of acute kidney injury or renal dialysis.\n5. Subject with uncontrolled blood pressure.\n6. Subject taking immunosuppressant.\n7. Subject with known or suspected hypersensitivity to any components of the APX-115 formulation.\n8. Clinically significant abnormal laboratory findings at screening.\n9. History of drug or alcohol abuse within 1 year prior to screening.\n10. History of any cardiovascular event or cardiovascular procedure planned during the clinical study.\n11. Current or history of New York Heart Association class III or IV heart failure.\n12. Clinically significant electrocardiogram (ECG) abnormalities.\n13. Known significant liver disease.\n14. Subject with active urinary tract infection or has not fully recovered before randomization.\n15. History of malignancy within 5 years prior to screening.\n16. Administration of any investigational product.\n17. Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months.\n18. Positive hepatitis B surface antigen.\n19. Female subject who is pregnant or breastfeeding.\n20. Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study.\n21. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.",{"count":83,"type":22},186,[85],"PHASE2","This study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and efficacy of Isuzinaxib compared with placebo in subjects with DKD.",[88],"Diabetic Kidney Disease (DKD)",[90,91,33,92,93,94,95],"Isuzinaxib","APX-115","Diabetic Nephropathy","DN","Diabetic Kidney Disease","DKD","2025-07-14",{"date":98,"type":38},"2025-07-18",{"date":100,"type":38},"2025-05-26",{"date":102,"type":22},"2028-06-30",{"name":44,"class":45},20,""]