Overview
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
Status:
Completed
Completed
Trial end date:
2018-02-08
2018-02-08
Target enrollment:
0
0
Participant gender:
All
All
Summary
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)Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
PRCL Research Inc.
Criteria
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)