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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05514353

Enrollment

Registered

2022-08-24

Start date

2021-12-28

Completion date

2023-01-12

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Psoriasis

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.

Interventions

DRUGPBI-100 Topical Cream

PBI-100 Topical Cream in 1 of 3 dose levels

DRUGVehicle Cream

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Number of Adverse Events (AEs) in Healthy Adult Subjects	From dosing until discharge, up to Day 28	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	From dosing until discharge, up to Day 28	To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026