Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Burn, Burn Wounds - Partial Thickness (2nd Degree)
In brief
This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.
Key facts
- Study ID
- NCT07025408
- Run by
- Shanghai Bao Pharmaceuticals Co., Ltd.
- People needed
- 144
- Starts
- 2025-06-16
- Expected to finish
- 2026-08-29
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;
- 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.
- 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.
You may not qualify if…
- Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.
- Burns caused by specific factors, such as electrical or chemical burns.
- Subjects with shock or inhalation lung injury;
- 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).
- Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;
- Abnormal liver or kidney function.
Where it is running
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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