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

Last updated: June 10, 2025
Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Skin Wounds

Hyponatremia

Treatment

Chymotrypsin

Placebo (Sodium Chloride Injection 0.9%)

KJ101

Clinical Study ID

NCT07025408
SHBJ-KJ101-002
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant norlactating;

  2. Clinically diagnosed with superficial or deep II degree burns within 72 hours ofinjury, with a total burn area of ≤30% TBSA. The target burn wound must be isolatedor have distinguishable boundaries, with an area between 40 and 200 cm².

  3. Subjects of childbearing age must agree to use effective and safe contraceptivemethods during the treatment period and for three months after the finaladministration.

Exclusion

Exclusion criteria:

  1. Individuals who are known to be allergic to any component of the test drug or whohave 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. atopicdermatitis, 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 severesystemic infections requiring systemic treatment;

  6. Abnormal liver or kidney function.

Study Design

Total Participants: 144
Treatment Group(s): 3
Primary Treatment: Chymotrypsin
Phase: 2
Study Start date:
June 16, 2025
Estimated Completion Date:
August 29, 2026

Study Description

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 in the debridement of deep second-degree burns. The aim is to provide supporting evidence for subsequent Phase III clinical trial.

The study comprises four treatment groups: KJ101 at a dose of 800 U/mL; KJ101 at a dose of 1200 U/mL; an active comparator group receiving chymotrypsin at a dose of 800 U/mL; and a placebo control group.

Approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. All interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement.

Treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.

Connect with a study center

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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