RecruitingPhase 2

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

China144 participantsStarted 2025-06-16

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Adverse events

Timeframe: day 35

Trial details

NCT IDNCT07025408

SponsorShanghai Bao Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Burn trials