KJ101 for debridement of deep second-degree burns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre, randomized, double-blind, dose-finding Phase II trial compares two doses of topical KJ101 (800 and 1200 U/mL) against chymotrypsin (800 U/mL) and placebo for debridement of deep second-degree burns. About 144 adults will be randomized 1:1:1:1 and receive local application once daily before debridement and then every other day after debridement for up to 28 days, with a one-week safety follow-up. The study will collect safety, efficacy, pharmacokinetic, and immunogenicity data to support later Phase III testing. Treatment continues until complete wound healing or the 28-day maximum.

Why it matters

Who can join: the full rules

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 ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².
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.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.