Anti-inflammatory treatment for dermatological disorders.

Exclusion Criteria44

• Subjects with erythrodermic, guttate, palmar, plantar or generalised pustular forms of psoriasis or subjects with scalp, palmar or plantar psoriasis only.
• Subjects with any skin condition other than psoriasis, in particular eczema, cutaneous infections, significant sun damage or an inherited skin disorder (other than psoriasis).
• History of allergy and/ or hypersensitivity to any of the stated ingredients of the formulations.
• A history of moderate to severe asthma during the last 10 years.
• Major chronic inflammatory disease e.g rheumatoid arthritis, Crohn’s disease, SLE.
• Congenital or acquired immunodeficiency or cancer prone syndrome.
• History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, Hepatitis C or HIV infection.
• Subjects who have smoked more than 10 cigarettes a day in the last 12 months
• History of malignancy (other than adequately treated skin carcinoma or carcinoma-in-situ of the cervix).
• Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study: systemic retinoids; immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil); phototherapy or photochemotherapy; high potency topical corticosteroids; “alternative medicine” treatments for psoriasis; or prolonged sun exposure or tanning bed use, which may in the opinion of the Investigator, modify disease activity.
• Topical treatment within 2 weeks prior to commencement of study treatment and for the duration of the study, including: moderate potency topical corticosteroids; vitamin D analogues and topical retinoids; or keratolytics, coal tar and dithranol.
• Have received any investigational research agent or therapeutic biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
• Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
• Use of any of the following prescription drugs: beta-blockers, diltiazem, verapamil, anti-arrhythmic drugs. Other prescription drugs may be allowed at the discretion of the Principal Investigator.
• Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, malignant, immunologic, psychiatric, metabolic or other uncontrolled systemic disease, with the exclusion of psoriasis.
• Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrolment, a history of suicide plan.
• Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG.
• History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
• Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
• Have clinical signs of active infection and/or a temperature of greater than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator.
• Have evidence of alcohol abuse within 6 months prior to screening visit (i.e., more than fourteen units of alcohol per week [1 Unit equal to 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
• Be unable to provide a pre-injection blood sample without undue trauma or distress.
• Anticipate surgery within the trial period or history of major surgery within 3 months of screening.
• History of hypersensitivity to the class of compound under investigation.
• Use of over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study treatment, except for topical products without systemic absorption.
• A depot injection or an implant of any drug within 3 months prior to administration of study treatment, with the exception of a contraceptive implant.
• Subjects with a history or presence (at screening or first baseline) of any clinically significant ECG abnormalities including, but not limited to any type pf AV blocks or any of the following ECG abnormalities on two or more tracings taken within 15 minutes at screening or baseline:
• (a) PR greater than 200 msec.
• (b) Any degree of atrio-ventricular block.
• (c) QRS complex greater than 120 msec.
• (d) QTcF greater than 470 msec (females) or greater than 450 msec (males).
• (e) Prominent U waves or any significant morphological changes other than non-specific T-wave changes.
• Subjects with a history or presence (at screening or first baseline) of any of the following cardiovascular findings:
• (a) Clinically significant ventricular or supraventricular arrhythmia (as judged by the investigator).
• (b) History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy or heart failure.
• (c) History or presence of long QT syndrome or any other cause of prolonged QT interval.
• (d) History or cardiac catheter ablation.
• (e) History or presence of symptomatic postural hypotension or syncopes.
• Subjects with a family history of congenital long QT syndrome or unexplained sudden cardiac death.
• Medications known to prolong the QTc interval.
• Subjects with symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction less than 20%, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study entry.
• Subjects who are unable to return for all scheduled study visits.
• Any other condition, that in the opinion of the investigator would render the subject unsuitable for enrolment, or could interfere with the subject participating in and completing the study.