NCT05514353

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy Volunteers
• Psoriasis

Interventions

Type	Name	Description
DRUG	PBI-100 Topical Cream	PBI-100 Topical Cream in 1 of 3 dose levels
DRUG	Vehicle Cream	The Vehicle Cream formulation contains the same excipients as the active cream

Timeline

• Start date: 2021-12-28
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2022-08-24
• Last updated: 2023-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study