A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis

Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

Inclusion Criteria:

Parts A and B

• Be 18 to 55 years old
• Be healthy with absence of clinically significant illness
• Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
• Female participants must be postmenopausal or surgically sterile
• Have venous access sufficient for blood sampling
• Be a non-smoker

Part C

• Be 18 to 75 years old
• Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
• Have at least 2 evaluable plaques located in at least 2 body regions

Exclusion Criteria:

Parts A and B

• Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
• Hepatic or renal impairment
• Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
• Female participants who are pregnant or breast feeding
• Recent or ongoing infection
• History of alcohol or drug abuse
• Current or recent enrollment in a clinical trial judged not compatible with this study

Part C

• Have highly active psoriatic arthritis
• Have pustular, erythrodermic and/or guttate forms of psoriasis
• Have had a clinically-significant flare of psoriasis during the last 12 weeks
• Currently or recently taking certain prescribed therapies for psoriasis
• Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)