[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594896":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":36,"locations":45,"responsibleParty":69,"collaborators":36,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":36,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":36,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":36,"overallStatus":48,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Shanghai Bao Pharmaceuticals Co., Ltd.","INDUSTRY",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental-KJ101-Dose Group -1","EXPERIMENTAL","KJ101 , Dose Group -1 (800 U\u002FmL)",[13],"Drug: KJ101",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental-KJ101-Dose Group -2","KJ101 , Dose Group -2 (1200 U\u002FmL)",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Active comparator","ACTIVE_COMPARATOR","Chymotrypsin (800 U\u002FmL)",[23],"Drug: Chymotrypsin",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo Comparator","PLACEBO_COMPARATOR","Placebo",[29],"Drug: Placebo (Sodium Chloride Injection 0.9%)",[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","KJ101","1. Clean the wound before applying medication.\n2. Apply KJ101 (800U\u002FmL) to the wound.\n3. Apply a standard wound dressing after treatment.\n4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).",[9,15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Chymotrypsin","1. Clean the wound before applying medication.\n2. Apply Chymotrypsin (800U\u002FmL) to the wound.\n3. Apply a standard wound dressing after treatment.\n4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).",[19],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Placebo (Sodium Chloride Injection 0.9%)","1. Clean the wound before applying medication.\n2. Apply Placebo (Sodium Chloride Injection 0.9%) to the wound.\n3. Apply a standard wound dressing after treatment.\n4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).",[25],[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200000","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61,66],{"name":62,"role":63,"phone":64,"phoneExt":36,"email":65},"Yan Liu","CONTACT","0086-021-34186000","rjliuyan@126.com",{"name":67,"role":68,"phone":36,"phoneExt":36,"email":36},"Yan Liu, MD","PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100594896","phase-2-phase-ii-clinical-trial-of-kj101in-the-treatment-of-deep-ii-degree-burns-100594896",false,"NCT07025408","Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns","A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns","Inclusion criteria:\n\n1. Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;\n2. Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².\n3. Subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration.\n\nExclusion criteria:\n\n1. Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.\n2. Burns caused by specific factors, such as electrical or chemical burns.\n3. Subjects with shock or inhalation lung injury;\n4. Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin).\n5. Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;\n6. Abnormal liver or kidney function.","ALL","18 Years","65 Years",{"count":82,"type":83},144,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.",[89,90],"Burn","Burn Wounds - Partial Thickness (2nd Degree)","2025-06-10",{"date":93,"type":94},"2025-06-17","ACTUAL",{"date":96,"type":83},"2025-06-16",{"date":98,"type":83},"2026-08-29",{"name":5,"class":6},1]