A Phase 1c, Single Centre Study Investigating the Safety and Tolerability of a Lysyl Oxidase Inhibitor (PXS-6302) vs Placebo in the Amelioration of Established Scars.

Exclusion Criteria16

• Subjects will be excluded from the study if one or more of the following criterion are applicable:
• 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 Investigator, would jeopardize the safety of the subject or impact the validity of the study results;
• Current acute skin condition (eg: eczema, psoriasis, broken skin, wounds etc) or large tattoos or excess hair at the study drug application site. Normal hair coverage and small blemishes are acceptable at the discretion of the Investigator.
• History of keloid scarring.
• History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease;
• Presence of a recent musculoskeletal injury or currently healing fracture;
• Have received or is anticipated to receive any prescription systemic or topical medication within 14 days prior to the start of dosing or within 5 half-lives of the study drug, whichever is greater, or use of any over-the-counter, complementary or alternative medicine 48 hours prior to the start of dosing (with the exception of paracetamol up to 2g per day, the use of intra-nasal and inhaled corticosteroids or antihistamines and vitamins);
• At Investigator discretion if systolic blood pressure <90 or >140 mmHg, diastolic blood pressure <50 or >95 mmHg, and heart rate <40 or >100 bpm;
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin
• >1.5 × upper limit of normal. Test may be repeated once at the discretion of the Investigator;
• Hemoglobin, white blood cell (WBC), neutrophils, platelets < lower limit of normal. Test may be repeated once at the discretion of the Investigator;
• Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula < 80 mL/min at Screening;
• Receipt of blood, or loss or donation of 450 mL or more of blood within 90 days or plasma donation within 14 days before the first dose administration;
• Have received an experimental therapy within 30 days or 5 half-lives of the study drug, whichever is longer, prior to dosing;
• Systemic infection other than common cold in the week prior to dosing.
• Pregnant females.