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

NCT03062618 | Completed Phase 1 FDA Drug

• 1 other identifier: PRCL-SMAD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Baseline up to approximately 73 days

Secondary Outcomes (33)

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

  Baseline up to 24 hours post-dose on day 2

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

  Baseline up to 24 hours post-dose on day 6

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

  Baseline up to approximately day 28

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

  Baseline up to approximately 45 days

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

  Baseline up to approximately 50 days

Study Arms (6)

Part A: Single Dose

EXPERIMENTAL

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

Drug: PRCL-02

Part A: Single Dose (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Part B: Multiple Dose

EXPERIMENTAL

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

Drug: PRCL-02

Part B: Multiple Dose (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Part C: Multiple Dose

EXPERIMENTAL

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

Drug: PRCL-02

Part C: Multiple Dose (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

PRCL-02 DRUG

Oral tablet(s) administered with water

Part A: Single Dose; Part B: Multiple Dose; Part C: Multiple Dose

Placebo Oral Tablet DRUG

Administered with water

Part A: Single Dose (Placebo); Part B: Multiple Dose (Placebo); Part C: Multiple Dose (Placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PRCL Research Inc.: lead

Study Sites (6)

Dr. Chih-ho Hong Medical Inc

Surrey, British Columbia, V3R 6A7, Canada

Location

Lynde Centre for Dermatology

Markham, Ontario, L3P 1X2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

K Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Dermatologie et Chirurgie Dermatologique

Montreal, Quebec, H3Z 2S6, Canada

Location

InVentiv Health

Québec, G1P 0A2, Canada

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Email PRCL@Choruspharma.com

  PRCL Research Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: February 20, 2017
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)