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.

Phase 1

• Conditions: burns; scarring; Skin - Other skin conditions; Injuries and Accidents - Burns; Surgery - Other surgery

• Registration Number: ACTRN12621001545853
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-12
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be eligible for study entry subjects must satisfy all of the following criteria:

1.Male or female and aged between 18 and 60 years (inclusive) at the screening visit;
2.Body Mass Index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 (inclusive) at the screening visit;
3.Have a scar duration between 1-5 years.
4.Adequate venous access in the left or right arm to allow collection of a number of blood samples;
5.A male subject is eligible to participate if he agrees to using one medically approved (i.e., mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug; Women of childbearing potential must use effective contraception. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence
6.Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.

Exclusion Criteria

Subjects will be excluded from the study if one or more of the following criterion are applicable:

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 Investigator, would jeopardize the safety of the subject or impact the validity of the study results;

2.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.

3.History of keloid scarring.

4.History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease;

5.Presence of a recent musculoskeletal injury or currently healing fracture;

6.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);

7.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;

8.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;

9.Hemoglobin, white blood cell (WBC), neutrophils, platelets < lower limit of normal. Test may be repeated once at the discretion of the Investigator;

10.Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula < 80 mL/min at Screening;

11.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;

12.Have received an experimental therapy within 30 days or 5 half-lives of the study drug, whichever is longer, prior to dosing;

13.Systemic infection other than common cold in the week prior to dosing.

14. Pregnant females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of multiple applications of PXS-6302 vs placebo in a target cohort. This will determined via the following:<br>Incidence and severity of adverse events (AE);<br>Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;<br>Clinically significant changes from baseline in:<br>Laboratory evaluations (hematology, chemistry)<br>Vital signs;<br>Physical examinations<br>[Primary timepoints are Day 7, 21, 28. At 2 months and Day 90. ]