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Safety Study of Ointment for the Treatment of Plaque-type Psoriasis

Last updated on March 14, 2019

Study Location
CMAX (A Division of IDT Australia Ltd)
Adelaide, , 5000 Australia
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque-type Psoriasis
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- White males, 18 - 55 years (inclusive) of age at the time of randomization.

- Body weight between 60-90 kg (Body Mass Index [BMI] between 19 and 30 kg/m2

- Willing and able to comply with study instructions and commit to all follow-up visits.

- Have adequate venous access to permit repeated PK sampling.

- Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior
to initiation of any protocol-related procedures.

- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine
patches, etc., for 6 months prior to the administration of the study medication).

For psoriasis patients (in addition to the above criteria):

- Clinical diagnosis of stable plaque-type psoriasis with active plaques involving
5%-20% of total BSA excluding face, scalp and groin.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History of serious adverse reactions or hypersensitivity to any drug; or known allergy
to any of the test product(s) or any components in the test product(s) or history of
hypersensitivity; or allergic reactions to any of the study preparations as described
in the Investigator's Brochure.

- Any clinically significant central nervous system (e.g., seizures), cardiac,
pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such
conditions that, in the opinion of the Investigator may place the subject at an
unacceptable risk as a participant in this trial or may interfere with the
distribution, metabolism or excretion of drugs.

- Abnormal physical findings of clinical significance at the Screening examination or
Baseline which would interfere with the objectives of the study.

- History of orthostatic hypotension (an increase in HR ?20 bpm accompanied by a ?20 mm
Hg drop in SBP and/or ?10 mm Hg drop in DBP) present at Screening.

- Clinically significant abnormal laboratory values (as determined by the Investigator)
at the Screening evaluation.

- Presence or history of allergies requiring acute or chronic treatment (except seasonal
allergic rhinitis).

- 12-lead ECG obtained at Screening with: PR >240 msec, QRS >110 msec and QTc >450 msec,
bradycardia ( ECG, or any other changes on the Screening ECG that would interfere with measurement
of the QT interval.

- Major surgical interventions within 6 months of the study.

- Has a positive pre-study Hepatitis B surface antigen; positive Hepatitis C (HCV)
antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result.

- Use of prescription or non-prescription drugs, including vitamin supplements, herbal
and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to
the first dose of study medication, or use of St. John's Wort within 28 days prior to
the first dose of study medication. However, the Investigator and study team can
review medication use on a case by case basis to determine if its use would compromise
subject safety or interfere with study procedures or data interpretation. By
exception, the subject may take paracetamol or acetaminophen (?2 g/day) or ibuprofen
(?1600 mg/day) up to 48 h prior to the first dose of study medication.

- Has a history of regular alcohol consumption averaging >14 drinks/week (1 drink [100
mL wine or 280 mL standard strength beer or 30 mL of 80 proof distilled spirits])
within 6 months of the Screening visit.

- Loss of 500 mL blood or more during the 3 month period before the study, e.g., blood

- People that follow vegetarian or vegan diets.

- Symptoms of a significant somatic or mental illness in the four week period preceding
drug administration.

- History of drug abuse or dependence within 12 months of the study.

- Positive pre-study urine drug and alcohol screen. A minimum list of drugs that will be
screened for include benzodiazepines, opiates, methadone metabolite (EDDP),
sympathomimetic amines, cannabinoids, barbiturates, cocaine, and ethanol. (Suspected
false positive results may be repeated at the discretion of the Investigator.)

- Concurrent or recent (within 60 days) participation in another drug or device research

- Considered by the Investigator to be unsuitable candidate for this study. Use of
AN2728 in a previous clinical trial.

For psoriasis patients (in addition to the above exclusion criteria):

- Spontaneously improving or rapidly deteriorating psoriatic plaques or
pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis.

- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from
beta blockers, calcium channel blockers, or lithium).

- Other serious skin disorder(s).

- Use of non-biologic systemic anti-psoriatic therapy (e.g., corticosteroids, PUVA, UVB,
retinoids, methotrexate, cyclosporine, other immunosuppressive agents) or biologic
therapy (e.g., alefacept, etanercept, adalimumab, ustekinumab) within four weeks prior
to enrollment or concurrently during the study.

- Use of topical treatments that have a known beneficial effect on psoriasis, including
but not limited to corticosteroids, retinoids, vitamin D derivatives, tar or
anthralin, within the past two weeks prior to enrollment or concurrently during the

- Systemic medications for other medical conditions that are known to affect psoriasis
(e.g., lithium, beta adrenergic blockers) within the past four weeks prior to
enrollment or concurrently during the study.

- Use of emollients/moisturizers on area(s) to be treated within two days prior to

Safety Study of Ointment for the Treatment of Plaque-type Psoriasis


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