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

NCT05514353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-03-29

No results posted yet for this 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.

Conditions

Interventions

DRUG

PBI-100 Topical Cream

PBI-100 Topical Cream in 1 of 3 dose levels

DRUG

Vehicle Cream

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

Sponsors & Collaborators

  • Pyramid Biosciences

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Pyramid Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2023-01-12
Completion
2023-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514353 on ClinicalTrials.gov