Back to resultsA Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
Primary Purpose
Healthy Volunteers, Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PBI-100 Topical Cream
Vehicle Cream
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
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
Sites / Locations
- TKL Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PBI-100 Topical Cream
Vehicle
Arm Description
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
Outcomes
Primary Outcome Measures
Number of Adverse Events (AEs) in Healthy Adult Subjects
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
To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514353
Brief Title
A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pyramid Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBI-100 Topical Cream
Arm Type
Experimental
Arm Description
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
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PBI-100 Topical Cream
Intervention Description
PBI-100 Topical Cream in 1 of 3 dose levels
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
The Vehicle Cream formulation contains the same excipients as the active cream
Primary Outcome Measure Information:
Title
Number of Adverse Events (AEs) in Healthy Adult Subjects
Description
To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
Time Frame
From dosing until discharge, up to Day 28
Title
Number of Adverse Events (AEs) in Adult Subjects with Psoriasis
Description
To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
Time Frame
From dosing until discharge, up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Pyramid Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
TKL Research Inc.
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
We'll reach out to this number within 24 hrs