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Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns

RecruitingPhase 2Ages 18 Years - 65 YearsAllShanghai Bao Pharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating; 2. Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of โ‰ค30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cmยฒ. 3. 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. Exclusion criteria: 1. Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies. 2. Burns caused by specific factors, such as electrical or chemical burns. 3. Subjects with shock or inhalation lung injury; 4. 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). 5. Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment; 6. Abnormal liver or kidney function.
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What it tests

  • KJ101
  • Chymotrypsin
  • Placebo (Sodium Chloride Injection 0.9%)
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Where

1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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