A Phase 1c Study Investigating the SAfety and TolErability of a LysyL Oxidase InhibiTor (PXS-6302) in the amElioration of Keloids

Exclusion Criteria13

• Auricular keloids;
• 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 (e.g.: eczema, psoriasis, broken skin, wounds etc.);
• Pregnant or breastfeeding women;
• Received treatment of keloid in the last 3 months;
• History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease;
• Are using or planning to use medications that will be applied to the area being treated in this study. There is no exclusion for other medications.
• At Investigator discretion if systolic blood pressure 140 mmHg, diastolic blood pressure 95 mmHg, and heart rate 100 bpm;
• At investigator’s discretion if 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;
• At investigator discretion if haemoglobin, white blood cell (WBC), neutrophils, platelets < 1.5x 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 < 60 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.