Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05514353 | A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream | PHASE1 | COMPLETED | 32 | — | — | Dec 28, 2021 | Jan 12, 2023 | Mar 29, 2023 | 1 | United States |
| NCT04882631 | A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants | PHASE1 | COMPLETED | 30 | — | — | Apr 12, 2021 | May 3, 2021 | Jan 27, 2022 | 1 | United States |
To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
To assess safety and tolerability of single and multiple doses of PBI-100 Topical Cream
Irritation potential based on the Cumulative Irritation Index (CII)
| Arm | Type | Description |
|---|---|---|
| PBI-100 Topical Cream | EXPERIMENTAL | 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 |
| Vehicle | PLACEBO_COMPARATOR | - |
| Cumulative Irritation Test | EXPERIMENTAL | Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications. |
| Name | Type | Description |
|---|---|---|
| PBI-100 Topical Cream | DRUG | PBI-100 Topical Cream in 1 of 3 dose levels |
| Vehicle Cream | DRUG | The Vehicle Cream formulation contains the same excipients as the active cream |
| Positive Control - Sodium laurel sulfate (SLS) | DRUG | Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site. |
| PBI-100 Topical Cream, Vehicle | OTHER | Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site. |
| Negative Control | OTHER | A blank patch was applied daily (excluding weekends) as a negative control test site. |
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 en...