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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат KJ101
  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).
• Препарат Chymotrypsin
  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).
• Препарат Placebo (Sodium Chloride Injection 0.9%)
  1. 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).

Первичные конечные точки

• Adverse events [Срок оценки: day 35]

Вторичные конечные точки (10)

• The time required for burn wounds to heal completely. [Срок оценки: day 3 to day 28]
• Rate of complete healing of burn wounds. [Срок оценки: day 28]
• The time it takes to completely remove necrotic tissue from burn wound. [Срок оценки: day 3 to day 28]
• Pain intensity evaluation (VAS score) [Срок оценки: day 1 to day 28]
• Pharmacokinetics of KJ101 (Cmax) [Срок оценки: day 28]
• Pharmacokinetics of KJ101 (AUC) [Срок оценки: day 28]
• Pharmacokinetics of KJ101 (t1/2) [Срок оценки: day 28]
• Pharmacokinetics of KJ101 (CL) [Срок оценки: day 28]
• Pharmacokinetics of KJ101 (Vz) [Срок оценки: day 28]
• Immunogenicity [Срок оценки: day 28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07025408 · SHBJ-KJ101-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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