Title
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)
Phase
Phase 1Lead Sponsor
PRCL Research Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
PsoriasisIntervention/Treatment
prcl-02 ...Study Participants
50This 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)
Oral tablet(s) administered with water
Administered with water
Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)
Two escalating sequences of matching placebo oral tablets, in 3 periods
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Multiple oral doses of placebo for 28 days, at matching dose levels
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Multiple oral doses of placebo for 28 days, at matching dose levels
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)
