A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Dec 2021
Longer than P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2021
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2023
CompletedMarch 29, 2023
March 1, 2023
1 year
August 22, 2022
March 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
PBI-100 Topical Cream
EXPERIMENTALSAD: 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
Vehicle
PLACEBO COMPARATORInterventions
The Vehicle Cream formulation contains the same excipients as the active cream
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TKL Research Inc.
Fair Lawn, New Jersey, 07410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Pyramid Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 24, 2022
Study Start
December 28, 2021
Primary Completion
January 12, 2023
Study Completion
January 12, 2023
Last Updated
March 29, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share