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

NCT ID: NCT05514353

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2023-01-12

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.

Conditions

Healthy Volunteers; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PBI-100 Topical Cream

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

Group Type: EXPERIMENTAL

PBI-100 Topical Cream

Intervention Type: DRUG

PBI-100 Topical Cream in 1 of 3 dose levels

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

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

Interventions

PBI-100 Topical Cream

PBI-100 Topical Cream in 1 of 3 dose levels

Intervention Type: DRUG

Vehicle Cream

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pyramid Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Pyramid Biosciences

Locations

TKL Research Inc.

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

PBI-100-102

Identifier Type: -

Identifier Source: org_study_id