Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Bao Pharmaceuticals Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
KJ101
Drug1. 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).
Chymotrypsin
Drug1. 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%)
Drug1. Clean the wound before applying medication. 2. Apply Placebo (Sodium Chloride Injection 0.9%) 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).
Treatment groups
144 Participants
are divided into 4 treatment groupsGroup A: Experimental-KJ101-Dose Group -1Experimental treatment 1 intervention
Group B: Experimental-KJ101-Dose Group -2Experimental treatment 1 intervention
Group C: Active comparatorActive comparator 1 intervention
Group D: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 35Secondary outcomes
1
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 282
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 283
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 284
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 28Sponsors and contacts
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Source ClinicalTrials.gov