[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EnnovaBio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100570516","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-enn0403-in-subjects-with-dme-100570516",false,"NCT06708260","A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME","A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n1. Provide written informed consent;\n2. Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;\n3. Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);\n4. The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;\n5. BCVA letter score of ≤ 73 (Snellen 20\u002F40) and ≥ 24 (Snellen 20\u002F320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ；\n6. Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.\n\nExclusion Criteria:\n\n1. Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;\n2. Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;\n3. Study eye had previously undergone vitreoretinal surgery;\n4. Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;\n5. Any eye received intraocular injection of VEGF within 3 months prior to baseline;\n6. History of idiopathic or autoimmune uveitis in any eye;\n7. Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)\n8. History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;\n9. Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);\n10. Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.",[27],"Diabetic Macular Edema (DME)","RECRUITING","2025-02-20",{"date":31,"type":32},"2025-02-21","ACTUAL",{"date":34,"type":32},"2024-12-12",{"date":36,"type":21},"2026-02",{"name":38,"class":39},"EnnovaBio","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100564702","phase-2-efficacy-and-safety-of-enn0403-in-patients-at-high-risk-for-acute-kidney-injury-following-elective-cardiac-surgery-100564702","NCT06632613","Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery","A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass","Inclusion Criteria:\n\n1. Ability to understand and comply with the study requirements and able to provide written informed consent;\n2. Age ≥18 and ≤85 years;\n3. Male subjects (and their fertile female spouses\u002Fpartners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. Only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: Postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an FSH \\>30 IU\u002FL in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \\\\ bilateral tubal resection and\u002For bilateral ovariectomy.\n4. Subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: Coronary artery bypass grafting (CABG) and\u002For heart valve surgery and\u002For aortic root, ascending aorta and aortic arch surgery;\n5. Subjects have the risk of developing AKI with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for AKI; Multiple heart valves surgery plus at least one AKI risk factor; Coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for AKI; Coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for AKI.\n\nExclusion Criteria:\n\n1. Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;\n2. Cardiopulmonary resuscitation is performed within 14 days prior to screening;\n3. Abnormal renal function with eGFR\\\u003C20 mL\u002Fmin\u002F1.73 m2 within 30 days before screening;\n4. Receive renal replacement therapy or the presence of AKI within 30 days before surgery, except for transient (≤5 days) stage 1 AKI after iodized contrast agent exposure;\n5. Participate in other clinical trials within the past 1 month;\n6. Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;\n7. Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.","85 Years",{"count":50,"type":21},200,[24],"The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.",[54],"Cardiac Surgery Associated - Acute Kidney Injury","2025-01-09",{"date":57,"type":32},"2025-01-13",{"date":59,"type":32},"2024-11-05",{"date":61,"type":21},"2026-03",{"name":38,"class":39},""]