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NCT05514353 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05514353
Other study ID # PBI-100-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 28, 2021
Est. completion date January 12, 2023

Study information
Verified date March 2023
Source Pyramid Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 12, 2023
Est. primary completion date January 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PBI-100 Topical Cream
PBI-100 Topical Cream in 1 of 3 dose levels
• Vehicle Cream
The Vehicle Cream formulation contains the same excipients as the active cream

Locations
Country Name City State
United States TKL Research Inc. Fair Lawn New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pyramid Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Events (AEs) in Healthy Adult Subjects To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream From dosing until discharge, up to Day 28
Primary 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 From dosing until discharge, up to Day 28
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