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

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.

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