Clinical trial NCT07025408: Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Official title: A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Burn
Burn Wounds - Partial Thickness (2nd Degree)
Lead sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Adverse events
timeFrame: day 35
Secondary outcomes:
measure: The time required for burn wounds to heal completely.
timeFrame: day 3 to day 28
measure: Rate of complete healing of burn wounds.
timeFrame: day 28
measure: The time it takes to completely remove necrotic tissue from burn wound.
timeFrame: day 3 to day 28
measure: Pain intensity evaluation (VAS score)
timeFrame: day 1 to day 28
measure: Pharmacokinetics of KJ101 (Cmax)
timeFrame: day 28
measure: Pharmacokinetics of KJ101 (AUC)
timeFrame: day 28
measure: Pharmacokinetics of KJ101 (t1/2)
timeFrame: day 28
measure: Pharmacokinetics of KJ101 (CL)
timeFrame: day 28
measure: Pharmacokinetics of KJ101 (Vz)
timeFrame: day 28
measure: Immunogenicity
timeFrame: day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: