Investigating targEting LysyL oxIdase tO ameliorate scarring in burn Trauma

Phase 1

• Conditions: burn injury; Skin - Other skin conditions; Injuries and Accidents - Burns

• Registration Number: ACTRN12623001071617
• Lead Sponsor: university of western australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-06
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified