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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBI-100 Topical Cream | Experimental | 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 |
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| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBI-100 Topical Cream | Drug | PBI-100 Topical Cream in 1 of 3 dose levels |
| |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Pyramid Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research Inc. | Fair Lawn | New Jersey | 07410 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Vehicle Cream |
| Drug |
The Vehicle Cream formulation contains the same excipients as the active cream |
|