临床试验/ACTRN12623001071617

ACTRN12623001071617尚未招募1 期

Investigating Safety and Preliminary Efficacy of TargEting LysyL oxIdase tO ameliorate scarring in burn Trauma

university of western australia0 个研究点目标入组 60 人开始时间: 2023年10月6日最近更新: 2023年10月23日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方: university of western australia
入组人数: 60

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 21 Years 至 60 Years（—）
性别: All

入选标准

•1.Aged between 21 and 60 years (inclusive).
•2.Acute burn injury of >=5% and <=15% total body surface area (TBSA) requiring treatment with a split-thickness skin graft
•3.Agree to use of adequate contraception if participant/partner of childbearing age.
•4.Have given written informed consent to participate in this study in accordance with local regulations.
•5. Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.

排除标准

•1.Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin, or cardiovascular disease or any other condition, that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
•2.History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease.
•3.Alanine aminotransferase (ALT) and/or), aspartate aminotransferase (AST) >3.0 x), or bilirubin>2.5 × upper limit of normal (ULN) or direct bilirubin >1.5 ULN.).
•4.Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 50 mL/min at Screening.
•5.Have participated in a clinical trial or have received an experimental therapy within 30 days or 5 half-lives of the drug, whichever is longer, prior to dosing.
•6.Active systemic infection
•7.History of aneurysm

研究者

发起方

university of western australia

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