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

Launched by SHANGHAI BAO PHARMACEUTICALS CO., LTD. · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KJ101 to help heal deep second-degree burns, which are burns that affect the outer and middle layers of the skin. The goal is to see if KJ101 is safe and effective at cleaning and preparing these burns for healing. This study will also look at how the medicine moves through the body and whether it causes any immune reactions. The results will help decide if KJ101 should be tested in larger future studies.

Adults between 18 and 65 years old who have deep or superficial second-degree burns covering up to 30% of their body and with wound sizes between 40 and 200 cm² may be eligible to join. The burns need to be recent, within 72 hours of injury, and clearly defined. People who are pregnant, have certain allergies, or specific types of burns (like electrical or chemical), or other serious health problems won’t be able to participate. If you join, you can expect to receive either the new treatment, an existing treatment, or a placebo (a treatment without active medicine) without knowing which one, to fairly test how well KJ101 works. Participants will be closely monitored for safety and healing progress throughout the study.

Gender

ALL

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.