| Eligibility |
Inclusion Criteria:
Part A
- Healthy male or female participants 18 to 65 years of age inclusive, at the time of
signing the informed consent.
- Male participants must agree to use contraception as detailed in the protocol
during the treatment period and for at least 90 days (a spermatogenesis cycle)
after the last dose of study drug and refrain from donating sperm during this
period.
o Male participants who have had a vasectomy with documentation of azoospermia
are not required to use contraception.
- Female participants must be of non-child bearing potential, defined as 1) at
least 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH)
> 40 milliInternational Units per milliliter (mIU/ml), or 2) having a documented
tubal ligation at least 6 weeks prior to dosing; or 3) having had a surgical
bilateral oophorectomy (with or without hysterectomy).
- Participants who are healthy as determined by the Investigator or medically qualified
designee based on a medical evaluation including medical history, physical
examination, laboratory tests, and cardiac monitoring.
- Participants with body mass index (BMI) within the range 18 to 30 kilograms per meters
squared (kg/m^2) (inclusive).
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the Informed Consent Form (ICF) and in this
protocol
- Willing to refrain from using any topical treatments, other than those mandated by the
protocol or for protocol procedures
Part B
- Male or female participants with mild to moderate psoriasis 18 to 65 years of age
inclusive, at the time of signing the informed consent
- Male participant must agree to use contraception as detailed in the protocol
during the treatment period and for at least 90 days (a spermatogenesis cycle)
after the last dose of study drug and refrain from donating sperm during this
period.
o Male participants who have had a vasectomy with documentation of azoospermia
are not required to use contraception.
- Female of non-child bearing potential is defined as 1) at least 12 months of
spontaneous amenorrhea with FSH > 40 mIU/mL, or 2) having a documented tubal
ligation at least 6 weeks prior to dosing; or 3) having had a surgical bilateral
oophorectomy (with or without hysterectomy).
- Participants who have a clinical diagnosis of stable plaque psoriasis for = 6 months,
as confirmed by the Investigator
- A Psoriasis Physician Global Assessment (PGA) score of = 2 at screening and Day 1
- At least 1 psoriasis plaque located on the trunk or extremities (excluding knees and
elbows) that is at least 5 centimeters squared (cm^2) in size at Screening and Day 1
with a Target Plaque Severity Score (TPSS) = 5 and induration subscore = 2
- Body Surface Area (BSA) involvement of psoriasis lesions between 2% and 15%, excluding
face, scalp, palms, soles, nails, and intertriginous areas at screening
- Participants with BMI within the range 18 to 35 kg/m^2 (inclusive)
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the ICF and in this protocol
- Willing to refrain from using any topical treatments, other than those mandated by the
protocol or for protocol procedures
Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, hematological, neurological, or skin disorders, in the Investigator's
opinion, may significantly alter the absorption, metabolism, or elimination of drugs;
constituting a risk when taking the study treatment; or interfering with the
interpretation of data
- Current evidence of any acute cutaneous infection, history of repeated or chronic
significant skin infections (unless irrelevant in the opinion of the Investigator,
i.e., onychomycosis, labial herpes or other minor diagnosis)
- Women of child-bearing potential, is pregnant, or is breastfeeding
- Known history of chronic hepatitis or human immunodeficiency virus (HIV); positive
findings of hepatitis B surface antigen or hepatitis C virus (HCV) antibody associated
with a positive HCV ribonucleic acid (RNA) polymerase chain reaction; or positive HIV
screening test suggesting active disease at the screening visit
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Abnormal blood pressure, liver, or renal function
- History of malignancy within 5 years prior to dosing, except adequately treated
non-invasive skin cancer (basal or squamous cell carcinoma)
- History of hypersensitivity to any of the study treatments, or components thereof, or
drug or other allergy that, in the opinion of the Investigator or medical monitor,
contraindicates participation in the study
- For Part A only: psoriasis of any kind (i.e., plaque, acute psoriasis guttate,
psoriasis punctata, psoriasis erythroderma, or pustular psoriasis)
- For Part A only: any clinically-relevant skin disease or other skin pathologies, that
may, in the opinion of the Investigator, contraindicate participation or interfere
with skin evaluations
- For Part A only: history or risk of complications from skin biopsy including impaired
wound healing, excess bleeding, infection, or scarring/keloid formation or known
hypersensitivity to local anesthetics. Use of anticoagulant medication.
- Use of prohibited concomitant medications or natural products within the defined
periods before the Day 1 visit and during the trial
- Current heavy smoker (those who smoke = 25 cigarettes a day) or former heavy smoker
who has stopped smoking within 1 month prior to screening
- Positive urine drug or alcohol test results during screening, or at Day 1, or history
of drug abuse within a year prior to the screening visit
- Excess alcohol consumption within 6 months prior to the study defined as an average
weekly intake of > 14 units for males and females. One unit is equivalent to 8 grams
of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL)
measure of spirits
- Donation or significant loss of blood within 3 months prior to screening, or plasma up
to 14 days prior to screening
- Participation in any clinical research study within 30 days or 5 half-lives, of the
investigational product, whichever is greater, prior to the screening visit
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