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

March 27, 2023 updated by: Pyramid Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • TKL Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Drug: Vehicle Cream
The Vehicle Cream formulation contains the same excipients as the active cream
Experimental: 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
Drug: PBI-100 Topical Cream
PBI-100 Topical Cream in 1 of 3 dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From dosing until discharge, up to Day 28
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
From dosing until discharge, up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pyramid Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2021

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

January 12, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBI-100-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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