PBI-100 Topical Cream for Psoriasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
TKL Research Inc., Fair Lawn, NJ
Psoriasis+1 More
PBI-100 Topical Cream - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Psoriasis
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Psoriasis

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: From dosing until discharge, up to Day 28

Day 28
Number of Adverse Events (AEs) in Adult Subjects with Psoriasis
Number of Adverse Events (AEs) in Healthy Adult Subjects

Trial Safety

Safety Progress

1 of 3

Other trials for Psoriasis

Trial Design

2 Treatment Groups

PBI-100 Topical Cream
1 of 2
Vehicle
1 of 2
Experimental Treatment
Non-Treatment Group

45 Total Participants · 2 Treatment Groups

Primary Treatment: PBI-100 Topical Cream · Has Placebo Group · Phase 1

PBI-100 Topical Cream
Drug
Experimental Group · 1 Intervention: PBI-100 Topical Cream · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle Cream · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PBI-100 Topical Cream
2021
Completed Phase 1
~30

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from dosing until discharge, up to day 28
Closest Location: TKL Research Inc. · Fair Lawn, NJ
2005First Recorded Clinical Trial
1 TrialsResearching Psoriasis
7 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, between 18 and 65 years of age.
You have a body mass index (BMI) between 18.0 and 32.0 kg/m2.
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.