Actively Recruiting
Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Led by Shanghai Bao Pharmaceuticals Co., Ltd. · Updated on 2025-06-17
144
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating
- Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of 30% TBSA
- Target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm
- Subjects of childbearing age must agree to use effective and safe contraceptive methods during treatment and for three months after final administration
You will not qualify if you...
- Known allergy to any component of the test drug or a tendency to allergies
- Burns caused by electrical or chemical factors
- Presence of shock or inhalation lung injury
- Target wounds complicated by inflammatory skin diseases such as atopic dermatitis, eczema, or psoriasis
- Prior enzymatic debridement treatment with agents like collagenase, papain, bromelain, chymotrypsin, or trypsin
- Severe systemic infections requiring systemic treatment as judged by the investigator
- Abnormal liver or kidney function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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