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

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 in the debridement of deep second-degree burns. The aim is to provide supporting evidence for subsequent Phase III clinical trial.

The study comprises four treatment groups: KJ101 at a dose of 800 U/mL; KJ101 at a dose of 1200 U/mL; an active comparator group receiving chymotrypsin at a dose of 800 U/mL; and a placebo control group.

Approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. All interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement.

Treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.

Inclusion criteria

• 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. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².
• 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

• Individuals who are known to be allergic to any component of the test drug or who have 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. atopic dermatitis, 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 severe systemic infections requiring systemic treatment;
• Abnormal liver or kidney function.