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.
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
