A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream

Study Overview
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Brief Summary
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This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study evaluating three dose levels of PBI-100 topical cream in healthy adult volunteers and/or subjects with psoriasis.

Detailed Description
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This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study. Three dose levels of PBI-100 topical cream will be evaluated in healthy adult volunteers and/or subjects with psoriasis. Dose escalations will follow a satisfactory review by the Safety Review Committee of all available safety, tolerability, and PK data from the current dose level.

Official Title
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A Phase 1, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Ascending Doses of PBI-100 Topical Cream in Healthy Adult Subjects and Subjects With Psoriasis

Conditions
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Healthy Volunteers, Psoriasis

Intervention / Treatment
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* Drug: PBI-100 Topical Cream
* Drug: Vehicle Cream


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Is male or female, between 18 and 65 years of age Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 Is in good general health, as determined by the Investigator, without clinically significant medical history, with the exception of psoriasis for those subjects enrolled in the psoriasis groups Key Exclusion Criteria: Has any visible skin disease (other than psoriasis for subjects in Groups 4 and 7) at the application site which, in the opinion of the Investigator, would interfere with the evaluation of the test site reaction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBI-100 Topical Cream<br>SAD: 4 cohorts of subjects are planned to receive a single dose of PBI-100 topical cream in one of three dosage strengths, administered once or twice daily MAD: 3 cohorts of subjects are planned to receive one of three dosage strengths of PBI-100 administered once or twice daily for periods of 14 consecutive days | Drug: PBI-100 Topical Cream<br>* PBI-100 Topical Cream in 1 of 3 dose levels<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle Cream<br>* The Vehicle Cream formulation contains the same excipients as the active cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) in Healthy Adult Subjects | To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream | From dosing until discharge, up to Day 28 | 
| Number of Adverse Events (AEs) in Adult Subjects with Psoriasis | To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream | From dosing until discharge, up to Day 28 |