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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Dose | Experimental | Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg) |
|
| Part A: Single Dose (Placebo) | Placebo Comparator | Two escalating sequences of matching placebo oral tablets, in 3 periods |
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| Part B: Multiple Dose | Experimental | Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels |
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| Part B: Multiple Dose (Placebo) | Placebo Comparator | Multiple oral doses of placebo for 28 days, at matching dose levels |
|
| Part C: Multiple Dose | Experimental | Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels |
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| Part C: Multiple Dose (Placebo) | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRCL-02 | Drug | Oral tablet(s) administered with water |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A | Mean change from baseline in triplicate 12-lead electrocardiogram (ECG) | Baseline up to 24 hours post-dose on day 2 |
| Change in Baseline in Triplicate 12-lead ECG in Part B |
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Inclusion Criteria:
Parts A and B
Part C
Exclusion Criteria:
Parts A and B
Part C
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| Name | Affiliation | Role |
|---|---|---|
| Email PRCL@Choruspharma.com | PRCL Research Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Chih-ho Hong Medical Inc | Surrey | British Columbia | V3R 6A7 | Canada | ||
| Lynde Centre for Dermatology |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 13, 2022 | |
| Reset | Feb 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2022 | Feb 16, 2023 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Multiple oral doses of placebo for 28 days, at matching dose levels
|
| Placebo Oral Tablet | Drug | Administered with water |
|
Mean change from baseline in triplicate 12-lead ECG
| 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 | 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 | Baseline up to approximately 45 days |
| Change from Baseline in Single 12-Lead ECG in Part B | Mean change from baseline in single 12-lead ECG | 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 | 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 | 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 | 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 | Baseline up to approximately 73 days |
| Number of participants with Physical Examination Findings in Part A | Abnormal physical exam findings | Baseline up to approximately 45 days |
| Number of participants with Physical Examination Findings in Part B | Abnormal physical exam findings | Baseline up to approximately 50 days |
| Number of participants with Physical Examination Findings in Part C | Abnormal physical exam findings | 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 | 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 | 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 | Baseline up to approximately 73 days |
| Maximum Observed Drug Concentration (Cmax) in Part A | Maximum observed plasma concentration of PRCL-02 | Baseline up to approximately 29 days |
| Maximum Observed Drug Concentration (Cmax) in Part B | Maximum observed plasma concentration of PRCL-02 | Baseline up to approximately 33 days |
| Maximum Observed Drug Concentration (Cmax) in Part C | Maximum observed plasma concentration of PRCL-02 | Baseline up to approximately 31 days |
| Time to Maximum Drug Concentration (Tmax) in Part A | Time to maximum plasma concentration of PRCL-02 | Baseline up to approximately 29 days |
| Time to Maximum Drug Concentration (Tmax) in Part B | Time to maximum plasma concentration of PRCL-02 | Baseline up to approximately 33 days |
| Time to Maximum Drug Concentration (Tmax) in Part C | Time to maximum plasma concentration of PRCL-02 | 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 | 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) | 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) | Baseline up to approximately 31 days |
| Minimum or Trough Concentration (Cmin) | Minimum or trough concentration of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag) | Time delay between administration of PRCL-02 and first observed plasma concentration | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Elimination Rate (Ke) | Elimination rate of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Terminal Elimination Half-Life (t1/2) | Terminal elimination half-life of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24) | Area under the plasma concentration time curve from time zero to 24 hours | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t) | Area under the plasma concentration time curve from time zero to the last observed time point | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Apparent Clearance (CL/F) | Apparent clearance of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Apparent Volume of Distribution (Vd/F) | Apparent volume of distribution of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Accumulation Ratio | Accumulation ratio of PRCL-02 | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) |
| Markham |
| Ontario |
| L3P 1X2 |
| Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| K Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Centre de Dermatologie et Chirurgie Dermatologique | Montreal | Quebec | H3Z 2S6 | Canada |
| InVentiv Health | Québec | G1P 0A2 | Canada |