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

PRCL Research Inc.50 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

PRCL-02DRUG

Oral tablet(s) administered with water

Placebo Oral TabletDRUG

Administered with water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (6)

Dr. Chih-ho Hong Medical Inc

Surrey, British Columbia, Canada

Lynde Centre for Dermatology

Markham, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

K Papp Clinical Research

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Events (Part A)

Number of participants with a serious adverse event, regardless of causality, by dose and treatment

Time frame: Baseline up to approximately 45 days

Number of Participants with One or More Serious Adverse Events (Part B)

Number of participants with a serious adverse event, regardless of causality, by dose and treatment

Time frame: Baseline up to approximately 50 days

Number of Participants with One or More Serious Adverse Events (Part C)

Number of participants with a serious adverse event, regardless of causality, by dose and treatment

Time frame: Baseline up to approximately 73 days

Secondary Outcomes

Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A

Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)

Time frame: Baseline up to 24 hours post-dose on day 2

Change in Baseline in Triplicate 12-lead ECG in Part B

Mean change from baseline in triplicate 12-lead ECG

Time frame: Baseline up to 24 hours post-dose on day 6

Change in Baseline in Triplicate 12-lead ECG in Part C

Mean change from baseline in triplicate 12-lead ECG

Time frame: Baseline up to approximately day 28

Change from Baseline in Single 12-Lead ECG in Part A

Mean change from baseline in single 12-lead ECG

Time frame: Baseline up to approximately 45 days

Data from ClinicalTrials.gov

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Centre de Dermatologie et Chirurgie Dermatologique

Montreal, Quebec, Canada

InVentiv Health

Québec, Canada

Change from Baseline in Single 12-Lead ECG in Part B

Mean change from baseline in single 12-lead ECG

Time frame: Baseline up to approximately 50 days

Change from Baseline in Single 12-Lead ECG in Part C

Mean change from baseline in single 12-lead ECG

Time frame: Baseline up to approximately 73 days

Number of Participants With Clinically Significant Changes in Vital Signs in Part A

Respiration Rate, Heart Rate, Blood Pressure, Temperature

Time frame: Baseline up to approximately 45 days

Number of Participants With Clinically Significant Changes in Vital Signs in Part B

Respiration Rate, Heart Rate, Blood Pressure, Temperature

Time frame: Baseline up to approximately 50 days

Number of Participants With Clinically Significant Changes in Vital Signs in Part C

Respiration Rate, Heart Rate, Blood Pressure, Temperature

Time frame: Baseline up to approximately 73 days

Number of participants with Physical Examination Findings in Part A

Abnormal physical exam findings

Time frame: Baseline up to approximately 45 days

Number of participants with Physical Examination Findings in Part B

Abnormal physical exam findings

Time frame: Baseline up to approximately 50 days

Number of participants with Physical Examination Findings in Part C

Abnormal physical exam findings

Time frame: Baseline up to approximately 73 days

Number of participants with Laboratory Test Results outside of reference range in Part A

Laboratory results outside of reference range

Time frame: Baseline up to approximately 45 days

Number of participants with Laboratory Test Results outside of reference range in Part B

Laboratory results outside of reference range

Time frame: Baseline up to approximately 50 days

Number of participants with Laboratory Test Results outside of reference range in Part C

Laboratory results outside of reference range

Time frame: Baseline up to approximately 73 days

Maximum Observed Drug Concentration (Cmax) in Part A

Maximum observed plasma concentration of PRCL-02

Time frame: Baseline up to approximately 29 days

Maximum Observed Drug Concentration (Cmax) in Part B

Maximum observed plasma concentration of PRCL-02

Time frame: Baseline up to approximately 33 days

Maximum Observed Drug Concentration (Cmax) in Part C

Maximum observed plasma concentration of PRCL-02

Time frame: Baseline up to approximately 31 days

Time to Maximum Drug Concentration (Tmax) in Part A

Time to maximum plasma concentration of PRCL-02

Time frame: Baseline up to approximately 29 days

Time to Maximum Drug Concentration (Tmax) in Part B

Time to maximum plasma concentration of PRCL-02

Time frame: Baseline up to approximately 33 days

Time to Maximum Drug Concentration (Tmax) in Part C

Time to maximum plasma concentration of PRCL-02

Time frame: Baseline up to approximately 31 days

Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A

Area under the plasma concentration-time curve from time 0 to infinity

Time frame: Baseline up to approximately 29 days

Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B

Area under the plasma concentration-time curve during the dosing interval of 24 hours (24h)

Time frame: Baseline up to approximately 33 days

Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C

Area under the plasma concentration-time curve during the dosing interval (24h)

Time frame: Baseline up to approximately 31 days

Minimum or Trough Concentration (Cmin)

Minimum or trough concentration of PRCL-02