Actively Recruiting
Phase II Randomised, Double-blind Trial Evaluating KJ101 for Wound Debridement in Deep Second-Degree Burns
Led by Shanghai Bao Pharmaceuticals Co., Ltd. · Updated on 2025-06-17
144
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
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 U/mL, KJ101 at 1200 U/mL, chymotrypsin at 800 U/mL, 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive local application of the assigned medication to the burn wound. The medication is applied once daily until complete removal of necrotic tissue, then every other day until the wound closes or up to 28 days.
Daily visits until debridement, then visits every other day until wound closure or Day 28
Duration - 1 week
Participants are monitored for safety after treatment completion for one week.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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