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

Pyramid Biosciences32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers Psoriasis

Interventions

PBI-100 Topical CreamDRUG

PBI-100 Topical Cream in 1 of 3 dose levels

Vehicle CreamDRUG

The Vehicle Cream formulation contains the same excipients as the active cream

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

TKL Research Inc.

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

Number of Adverse Events (AEs) in Healthy Adult Subjects

To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream

Time frame: 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

Time frame: From dosing until discharge, up to Day 28

Data from ClinicalTrials.gov

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