[{"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:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,65],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100647063","phase-1-a-first-in-human-sadmad-study-to-evaluate-safety-tolerability-and-pk-of-enc0653-ointment-in-healthy-adult-subjects-100647063",false,"NCT07684196","A First-in-Human SAD\u002FMAD Study to Evaluate Safety, Tolerability and PK of ENC0653 Ointment in Healthy Adult Subjects","A Phase 1 Randomized, Double-Blind, Single-Center, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose (SAD\u002FMAD) Study by Topical Dermal Administration to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC0653 Ointment in Healthy Adult Subjects","Inclusion Criteria:\n\n* The subject signs the informed consent form (ICF) prior to enrollment after full disclosure of study procedures and requirements. The subject understands the necessity of following study rules and completing all assessments on time, is fully informed of study procedures, and potential adverse reactions, and is able to complete the study in accordance with the protocol requirements.\n* Aged ≥ 18 years and ≤ 55 years on the date of signing the informed consent form, male or female.\n* Male subjects with body weight ≥ 50 kg, female subjects with body weight ≥ 45 kg, and body mass index (BMI) within the range of 18.0-32.0 kg\u002Fm² (inclusive).\n* No ulceration, injury, sunburn, erythema, rash, or abnormal warmth, as well as tattoos, birthmarks, skin scars, or skin perforations shall be present on the target application regions at screening and prior to dosing.\n* The subject gives voluntary consent to employ adequate contraceptive methods from 2 weeks prior to dosing until 1 month after the last study visit, and to refrain from sperm or egg donation during this period.\n\nExclusion Criteria:\n\n* The subject has any skin disorders deemed by the investigator to be a study contraindication or to compromise assessment of the application region, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, other dermatologic lesions, or a history of cutaneous malignancy.\n* Presence of any of the following high-risk conditions: history of deep vein thrombosis, arterial thrombosis, or pulmonary embolism; family history of thromboembolism (e.g., myocardial infarction or cerebral infarction in family members); history of malignancy; serious organ or systemic disease, immune-mediated disease (including but not limited to rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc.), or any diseases deemed by the investigator to render the subject unsuitable for enrollment in this study.\n* Presence of any active cutaneous infections of acute bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, varicella, etc.) within 1 week prior to signing the ICF; or any acute or chronic infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to signing the ICF.\n* History of severe trauma or major surgery within 3 months prior to screening; plan to receive surgery during the trial or within 2 weeks after completion of the trial.\n* History of active tuberculosis, or clinical symptoms\u002Fsigns or chest X-ray findings suggestive of active tuberculosis.\n* Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody (TP-Ab).\n* Pregnant, breast-feeding and\u002For lactating women.\n* ALT, AST or TBiL ≥1.5ULN\n* Has received any live vaccines within 1 month prior to screening or intend to receive a live vaccine during the study period or within 30 days after the last dose.\n* The subject who has participated in any clinical trial of investigational drugs or medical devices within 3 months prior to screening (or 5 half-lives, whichever is longer).\n* Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a FIH, randomized, double-blind, single-center, placebo-controlled, dose -escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of ENC0653 ointment following single and multiple topical dermal administration in healthy adult subjects.\n\nUp to 56 subjects will be enrolled at a single site in up to 4 cohorts in Part A (SAD study), and up to 3 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is twice-daily use for 7 consecutive days and once daily use on Day 8. Each cohort will include 8 subjects (6 receiving ENC0653 ointment and 2 receiving placebo ointment).\n\nDosing will be escalated on a review of safety, tolerability, and available PK data by a Safety Review Committee (SRC).",[28],"Healthy","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-06","ACTUAL",{"date":35,"type":22},"2026-06-17",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"EnnovaBio","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100570516","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-enn0403-in-subjects-with-dme-100570516","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.","80 Years",{"count":51,"type":22},60,[53],"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.",[56],"Diabetic Macular Edema (DME)","2025-02-20",{"date":59,"type":33},"2025-02-21",{"date":61,"type":33},"2024-12-12",{"date":63,"type":22},"2026-02",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"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":74,"type":22},200,[53],"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.",[78],"Cardiac Surgery Associated - Acute Kidney Injury","2025-01-09",{"date":81,"type":33},"2025-01-13",{"date":83,"type":33},"2024-11-05",{"date":85,"type":22},"2026-03",{"name":39,"class":40},""]