Phase
Condition
Skin Wounds
Hyponatremia
Treatment
Chymotrypsin
Placebo (Sodium Chloride Injection 0.9%)
KJ101
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant norlactating;
Clinically diagnosed with superficial or deep II degree burns within 72 hours ofinjury, with a total burn area of ≤30% TBSA. The target burn wound must be isolatedor have distinguishable boundaries, with an area between 40 and 200 cm².
Subjects of childbearing age must agree to use effective and safe contraceptivemethods during the treatment period and for three months after the finaladministration.
Exclusion
Exclusion criteria:
Individuals who are known to be allergic to any component of the test drug or whohave a tendency to allergies.
Burns caused by specific factors, such as electrical or chemical burns.
Subjects with shock or inhalation lung injury;
Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopicdermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g.with collagenase, papain, bromelain, chymotrypsin or trypsin).
Subjects who, during screening, are judged by the investigator to have other severesystemic infections requiring systemic treatment;
Abnormal liver or kidney function.
Study Design
Study Description
Connect with a study center
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200000
ChinaActive - Recruiting

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