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

Pyramid Biosciences

Status and phase: Completed; Phase 1

Conditions: Psoriasis; Healthy Volunteers

Treatments: Drug: Vehicle Cream; Drug: PBI-100 Topical Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05514353

PBI-100-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

PBI-100 Topical Cream

Experimental group

Description:

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

Treatment:

Drug: PBI-100 Topical Cream

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle Cream