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
Shanghai Bao Pharmaceuticals Co., Ltd.
144 participants
Jun 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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).
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).
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)
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For the most up-to-date information, visit the official listing.
NCT07025408