[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleurisy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleurisy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100556451","phase-1-a-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-osrhct-in-patients-with-pleurisy-100556451",false,"NCT06525272","A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy","A Phase 1 Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT Administered Intrathoracically in Single and Multiple Doses in Patients With Pleurisy","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent;\n2. Aged 18-65 years (inclusive), male or female;\n3. Clinical diagnosis of pleurisy (parapneumonic pleural effusion, empyema, tuberculous pleurisy, etc.);\n4. Patients with pleural effusion confirmed by chest ultrasound or CT examination and requiring chest tube drainage as assessed by the study physician, and the ultrasound report or CT image within one month shows that there are fibrous bands or encapsulated or septated effusions in the thoracic cavity;\n5. Patients who cannot be fully drained after open drainage for ≥ 3 hours after chest tube drainage and meet the following conditions: The maximum depth of pleural effusion detected by ultrasound is ≥ 2 cm;\n6. Women of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and within 3 months after the end of the study; men must agree to use effective contraception during the study and within 3 months after the end of study period.\n\nExclusion Criteria:\n\n1. Known allergy to the investigational drug or its excipients;\n2. Known or clinically highly suspected malignant pleural effusion;\n3. Received intrathoracic injection of fibrinolytic drugs (such as urokinase, streptokinase, and alteplase) within 1 month prior to enrollment;\n4. History of lung resection surgery on the same side as the chest tube drainage;\n5. Evidence of abdominal lesions (e.g., pancreatic cyst or renal cyst) communicating with the pleura;\n6. Currently using systemic corticosteroids and unable to discontinue;\n7. HIV antibody positive;\n8. History of organ transplantation;\n9. Severe cardiovascular, cerebrovascular, hematologic diseases, or malignancies;\n10. Abnormal laboratory values: hemoglobin \\\u003C80g\u002FL, total bilirubin \\>2×ULN (upper limit of normal), ALT \\>2.5×ULN, AST \\>2.5×ULN, creatinine \\>2×ULN; coagulation function APTT \\>1.5×ULN, or INR \\>1.5;\n11. Pregnant or breastfeeding women;\n12. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months (excluding diagnostic skin test);\n13. Any other conditions deemed unsuitable for the study by the investigator.","ALL","18 Years","65 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Primary Objectives:\n\nTo evaluate the safety and tolerability of single and multiple ascending doses of OsrhCT administered intrathoracically in patients with pleurisy, and to explore the DLT, MTD, and recommended effective dose of OsrhCT.\n\nSecondary Objectives:\n\nTo evaluate the preliminary efficacy of single and multiple intrathoracic doses of OsrhCT.\n\nPopulation:\n\nPatients diagnosed with pleurisy requiring chest tube drainage.\n\nInvestigational Products:\n\nInvestigational Drug: Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U\u002Fvial, freeze-dried powder, stored at 2-8°C.\n\nPlacebo:\n\nPlacebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.\n\nStudy Design:\n\nThe study comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), both employing a multicenter, randomized, double-blind, and placebo-controlled design.\n\nSample Size:\n\nA total of 72 subjects (both male and female) are expected to be enrolled in this trial, including 48 subjects for single-dose administration and 24 subjects for multiple-dose administration.",[27],"Pleurisy",[29,30],"OsrhCT","Recombinant Human Chymotrypsin","NOT_YET_RECRUITING","2024-07-24",{"date":34,"type":35},"2024-07-29","ACTUAL",{"date":37,"type":21},"2024-07",{"date":39,"type":21},"2025-12",{"name":41,"class":42},"Healthgen Biotechnology Corp.","INDUSTRY",4]