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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental-KJ101-Dose Group -1
KJ101 , Dose Group -1 (800 U/mL)
干预措施: KJ101 (Drug)
Experimental-KJ101-Dose Group -2
KJ101 , Dose Group -2 (1200 U/mL)
干预措施: KJ101 (Drug)
Active comparator
Chymotrypsin (800 U/mL)
干预措施: Chymotrypsin (Drug)
Placebo Comparator
Placebo
干预措施: Placebo (Sodium Chloride Injection 0.9%) (Drug)
结局指标
主要结局
Adverse events
时间窗: day 35
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.
次要结局
- The time required for burn wounds to heal completely.(day 3 to day 28)
- Rate of complete healing of burn wounds.(day 28)
- The time it takes to completely remove necrotic tissue from burn wound.(day 3 to day 28)
- Pain intensity evaluation (VAS score)(day 1 to day 28)
- Pharmacokinetics of KJ101 (Cmax)(day 28)
- Pharmacokinetics of KJ101 (AUC)(day 28)
- Pharmacokinetics of KJ101 (t1/2)(day 28)
- Pharmacokinetics of KJ101 (CL)(day 28)
- Pharmacokinetics of KJ101 (Vz)(day 28)
- Immunogenicity(day 28)