What is KJ101 studying for deep second-degree burns?

KJ101 is being studied to understand its safety, effectiveness, how the body processes it, and immune response when used to remove dead tissue from deep second-degree burns. This trial aims to provide important information to support future research. It is sponsored by Shanghai Bao Pharmaceuticals Co., Ltd.

Who may be eligible for this burn wound clinical trial?

Adults aged 18 to 65 with superficial or deep second-degree burns within 72 hours, and a burn area of 30% or less of total body surface may be eligible. Both males and females who are not pregnant or lactating can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this burn wound clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID07025408

Phase II Study to Assess the Safety and Effectiveness of KJ101 for Treating Deep Second-Degree Burns

Led by Shanghai Bao Pharmaceuticals Co., Ltd. · Updated on 2025-06-17

144

Participants Needed

Research Sites

23 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter, randomized, double-blind Phase II clinical trial to study the safety, effectiveness, and immune response of KJ101 for removing dead tissue in deep second-degree burns. This trial also examines how the body processes KJ101 and will help support future Phase III studies. The study compares different doses of KJ101 with an active drug, chymotrypsin, and a placebo. Participants will be assigned to one of four groups KJ101 at 800 UmL, KJ101 at 1200 UmL, chymotrypsin at 800 UmL, or placebo. All treatments are applied locally to the burn wound once daily until the dead tissue is fully removed, then every other day until the wound heals or up to 28 days. After treatment ends, there is a one-week safety follow-up. During the study, participants will undergo assessments of wound healing time, pain levels, and removal of dead tissue. Blood tests will measure drug levels and immune responses. The main outcome is monitoring adverse events by day 35. The total study duration includes treatment up to 28 days plus a safety follow-up week.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Male and female subjects aged 18 to 65 years, not pregnant or lactating
Diagnosed with superficial or deep second-degree burns within 72 hours of injury
Total burn area of 30% or less of total body surface area
Target burn wound isolated or with clear boundaries, sized 40 to 200 cm²
Subjects of childbearing potential agree to use effective contraception during treatment and for 3 months after final dose

You will not qualify if you...

Known allergy to any component of the test drug or history of allergies
Burns caused by electrical or chemical sources
Presence of shock or inhalation lung injury
Target wounds complicated by inflammatory skin diseases or previous enzymatic debridement
Severe systemic infections requiring systemic treatment
Abnormal liver or kidney function

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