KJ101 for debridement of deep second-degree burns

A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns

This trial will test whether topical KJ101 helps remove dead tissue and promote healing in adults with deep second-degree burns compared with chymotrypsin and placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07025408 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 with isolated or clearly bounded deep second-degree burns within 72 hours of injury, total burn area ≤30% TBSA, and a target wound of 40–200 cm² who are not pregnant or lactating and agree to contraception if applicable.

Not a fit: Patients with electrical or chemical burns, inhalation injury or shock, target wounds with inflammatory skin disease, known allergy to study drug components, prior enzymatic debridement of the target wound, or those who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, KJ101 could provide a safer or more effective enzymatic option to remove necrotic tissue and speed healing of deep second-degree burns, potentially reducing the need for surgical debridement.

How similar studies have performed: Enzymatic debridement using agents like chymotrypsin and collagenase has clinical precedent and demonstrated utility, but KJ101 is a novel enzymatic agent being directly compared against an active comparator and placebo.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

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

Conditions Burn; Burn Wounds - Partial Thickness