Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
Brief Summary: This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.


Options:
A: Inclusion Criteria:

* Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
* Have moderate-to-severe psoriasis in the genital area at screening and baseline.
* Have plaque psoriasis in a nongenital area at screening and baseline.
* Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
* Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis.
* History of drug-induced psoriasis.
* Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
* Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
* Are currently enrolled in any other clinical trial involving an investigational product.
* Serious disorder or illness other than plaque psoriasis.
* Active or history of malignant disease within 5 years prior to baseline.
* Serious infection within the last 3 months.
* Have received a live vaccine within 3 months of baseline or plan to do so during the study.
* Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
* Pregnant or breastfeeding (lactating) women.
B: Inclusion Criteria:

* patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
* patients eligible for systemic therapy with inadequately controlled psoriasis

Exclusion Criteria:

* forms of sporiasis other than plaque type psoriasis
* previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA

Other protocol-defined inclusion/exclusion criteria may apply
C: Inclusion Criteria:

* 18-80 years old and capable of giving informed consent.
* at least a 6-month history of chronic moderate to severe psoriasis and a candidate for systemic therapy.
* BSA covered with psoriasis of at least 5 % or more at Baseline.
* An history of coronary atherosclerosis or at least three risk factors among the following: hypertension, active smoking, diabetes mellitus, dyslipidemia, obesity, microalbuminuria, age above 55 years, and first degree relative with coronary atherosclerosis before 65 years.
* Patient must be on a stable dose for at least 8 weeks before baseline if taking medications used to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation.
* Patient has a carotid or ascending aorta atherosclerotic plaque inflammation target-to background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
* Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:

  * condoms, sponge, foams, jellies, diaphragm or IUD.
  * contraceptives for three months prior to study drug administration
  * a vasectomized partner.
* Female patient of childbearing potential must have a negative serum pregnancy test at the Screening visit.
* Patient is judged to be in good general health as determined by the principal investigator.
* Patient will be evaluated for latent TB infection with a PPD or a Quantiferon Gold test and CXR. Patient who demonstrates evidence of latent TB infection will only be allowed to participate in the study if they are willing to use TB prophylaxis according to Canadian guidelines
* Patient must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
* Patient must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.

Exclusion Criteria:

* Patient has other active skin diseases or skin infections (that may interfere with evaluation of psoriasis or with patient's safety.
* Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex.
* Patient used any non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0. Investigational chemical agents must be discontinued at least 30 days or five half-lives prior to the Baseline visit (whichever is longer).
* Patient who has used any biological therapy for the treatment of psoriasis less than 3 months (90 days) before Day 0.
* Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
* Patient has used any topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to baseline (at the exception of low strength (hydrocortisone and desonide) topical corticosteroid for the face, groin (including genitals) and inframammary areas).
* Patient has received Anakinra/Kineret within the last 2 weeks prior to the Baseline visit or is likely to receive Anakinra/Kineret during the course of the study.
* Patient has a poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure a left ventricular ejection fraction of less than 40%, recent stroke, chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.
* Patient had a myocardial infarction or hospitalization for a cardiac condition within the past 12 weeks.
* Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, or carotid revascularization within 12 weeks of baseline.
* Patient for whom a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation is planned for the duration of the study.
* Patient has a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
* Patient has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
* Patient has a history of listeriosis, treated or untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
* Patient has received any live attenuated vaccine 28 days or less before baseline.
* Patient with hepatitis B or hepatitis C viral infection.
* Patient with any of the following: hemoglobin = 10 g/L, white blood cell count = 3.0 X 109/L, platelet count =130 X 109/L, ALT = 2 times the upper limit of normal, AST = 2 times the upper normal limit, total bilirubin = 2 times the upper normal limit or creatinine = 150 umol/L.
* Patient is currently using or plans to use anti-retroviral therapy at any time during the study.
* Patient is known to have immune deficiency or is immunocompromised.
* Female patient who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication.
* Patient has a history of clinically significant drug or alcohol abuse in the last year.
* Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
D: Inclusion Criteria:

Part A:

* Able to provide written informed consent
* Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
* Additional inclusion criteria apply

Part B:

* 18 - 55 years old inclusive at Screening
* Active but clinically stable, plaque psoriasis
* Psoriasis involving ≥ 10% of the body surface area
* A minimum PASI score of ≥ 10 obtained during the screening period
* Additional inclusion criteria apply

Exclusion Criteria:

Part A:

* History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c \> 7%, history of splenectomy)
* Additional exclusion criteria apply

Part B:

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
* Additional exclusion criteria apply

Answer: D