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

Phase 2RecruitingNCT07025408

Shanghai Bao Pharmaceuticals Co., Ltd.144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

144

Conditions

Burn Burn Wounds - Partial Thickness (2nd Degree)

Interventions

KJ101DRUG

1. Clean the wound before applying medication. 2. Apply KJ101 (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).

ChymotrypsinDRUG

1. Clean the wound before applying medication. 2. Apply Chymotrypsin (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).

Placebo (Sodium Chloride Injection 0.9%)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Adverse events

Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame: day 35

Secondary Outcomes

The time required for burn wounds to heal completely.

The time taken for the burn wound to reach full epithelialisation, i.e. complete healing.

Time frame: day 3 to day 28

Rate of complete healing of burn wounds.

The complete burn wound healing rate was calculated as follows: (Number of subjects with complete burn wound healing within 28 days of randomisation/Total number of subjects) x 100%. Complete wound healing of burn wounds in patients was assessed using the criterion of 100% epithelialisation of the burn wound.

Time frame: day 28

The time it takes to completely remove necrotic tissue from burn wound.

Necrotic tissue in a wound was defined as inactive tissue that had lost its ability to heal due to irreversible cell death caused by thermal injury. The complete removal of necrotic tissue from a burn wound was defined as the point at which the wound was fully cleared of necrotic tissue, the base was clean, and new tissue had formed.

Time frame: day 3 to day 28

Pain intensity evaluation (VAS score)

A visual analogue scale (VAS) is used to assess pain. The basic method involves a 10 cm scale divided into 10 points, with '0' and '10' at each end. '0' represents no pain, while '10' represents the most severe and intolerable pain possible.

Time frame: day 1 to day 28

Pharmacokinetics of KJ101 (Cmax)

Maximum observed serum concentration of KJ101 following dosing (Cmax)

Data from ClinicalTrials.gov

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