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

Phase 1

Completed

• Conditions: Psoriasis; Healthy Volunteers
• Interventions: Drug: Vehicle Cream; Drug: PBI-100 Topical Cream

• Registration Number: NCT05514353
• Lead Sponsor: Pyramid Biosciences

Brief 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.

Study Timeline

• Study Start: 2021-12-28
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle Cream	-
PBI-100 Topical Cream	PBI-100 Topical Cream	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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs) in Healthy Adult Subjects	From dosing until discharge, up to Day 28	To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
Number of Adverse Events (AEs) in Adult Subjects with Psoriasis	From dosing until discharge, up to Day 28	To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream

Trial Locations

Locations (1)

TKL Research Inc.; 🇺🇸 Fair Lawn, New Jersey, United States