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Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-06-16
Completion Date
2026-08-29
Last Updated
2025-06-17
Healthy Volunteers
No
Interventions
KJ101
1. Clean the wound before applying medication. 2. Apply KJ101 (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. 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).
Chymotrypsin
1. Clean the wound before applying medication. 2. Apply Chymotrypsin (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. 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).
Placebo (Sodium Chloride Injection 0.9%)
1. Clean the wound before applying medication. 2. Apply Placebo (Sodium Chloride Injection 0.9%) to the wound. 3. Apply a standard wound dressing after treatment. 4. 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).
Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China