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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-02-08

Brief Summary

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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)

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Single Dose

Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)

Group Type EXPERIMENTAL

PRCL-02

Intervention Type DRUG

Oral tablet(s) administered with water

Part A: Single Dose (Placebo)

Two escalating sequences of matching placebo oral tablets, in 3 periods

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Administered with water

Part B: Multiple Dose

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels

Group Type EXPERIMENTAL

PRCL-02

Intervention Type DRUG

Oral tablet(s) administered with water

Part B: Multiple Dose (Placebo)

Multiple oral doses of placebo for 28 days, at matching dose levels

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Administered with water

Part C: Multiple Dose

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels

Group Type EXPERIMENTAL

PRCL-02

Intervention Type DRUG

Oral tablet(s) administered with water

Part C: Multiple Dose (Placebo)

Multiple oral doses of placebo for 28 days, at matching dose levels

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Administered with water

Interventions

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PRCL-02

Oral tablet(s) administered with water

Intervention Type DRUG

Placebo Oral Tablet

Administered with water

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes