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Completed

NCT Number: NCT05514353

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

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.

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Key information

Conditions

Healthy Volunteers Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBI-100 Topical Cream

Drug

PBI-100 Topical Cream in 1 of 3 dose levels

Vehicle cream

Drug

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

Primary outcomes

  1. Number of Adverse Events (AEs) in Healthy Adult Subjects

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

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

  2. Number of Adverse Events (AEs) in Adult Subjects with Psoriasis

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

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

Sponsors and collaborators

Lead sponsor

Pyramid Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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