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PBI-100 · 2 trials · 2 indications
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...
PBI-100 is an investigational small molecule being developed as a topical cream for dermatology use. It has been studied in healthy volunteers and in a trial that included participants with psoriasis. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
PBI-100 is being developed by Biohaven Ltd., a biopharmaceutical company traded on the New York Stock Exchange under the ticker BHVN. The company is conducting clinical trials of the topical cream formulation in the United States.
PBI-100 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in the United States, with a total enrollment of 62 participants. The drug is investigational and has not received FDA approval.
PBI-100 has completed two Phase 1 trials. NCT04882631 evaluated skin irritation potential of the topical cream in 30 healthy participants. NCT05514353 assessed single and multiple ascending doses in 32 participants with healthy volunteers and psoriasis. Both trials were randomized, double-blind, and placebo-controlled.
PBI-100 is the primary name used for this investigational topical cream developed by Biohaven Ltd. No alternative names have been reported in the clinical trial records. The drug is being studied under the identifiers NCT04882631 and NCT05514353.