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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
| Swiss TPH, Basel, Switzerland | UNKNOWN |
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All enrolled participants will be randomized to 3 cohorts with 8 participants each and will receive BAP5191 and placebo topically on a square of 121 cm2 each in the left and right scapula region daily for 28 days, with a 28-d safety follow-up.
The squares will be covered with a semi-occlusive patch. The doses will escalate from Cohort 1 to Cohort 2 to Cohort 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 1 mg/mL (0.1%) BAC6027 formulation; placebo |
|
| Cohort 2 | Experimental | 5 mg/mL (0.5%) BAC6027 formulation; placebo |
|
| Cohort 3 | Experimental | 10 mg/mL (1.0%) BAC6027 formulation; placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAP5191 | Drug | Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| General safety (number, frequency, severity, seriousness and duration of adverse events) | Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events. | From day 0 to day 55 |
| Blood pressure from baseline | Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed. | From day 0 to day 55 |
| Heart rate from baseline | Change of pulse rate from baseline. | From day 0 to day 55 |
| Respiratory rate from baseline | Change of respiratory rate from baseline. | From day 0 to day 55 |
| Temperature from baseline | Change of tympanic temperature from baseline. | From day 0 to day 55 |
| ECG parameters from baseline | Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline. | From day 0 to day 55 |
| Local skin tolerability: dermal response score | Summarized statistics of tolerability assessment based on dermal response score and other effects score. The dermal response score ranges from score 0 (better, No evidence of irritation) to score 7 (worse, Strong reaction spreading beyond test site). |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of BAC6027 | Peak Plasma Concentration (Cmax) of BAC6027, if detectable. | during the procedure, day 0 - day 31 |
| Tmax of BAC6027 | Time to reach Cmax (Tmax), in case of plasma concentration determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological findings of skin biopsies taken after completion of treatment on Day 31. | Description of histopathological observations by application site and dose administered. | after the last PK sample collection, Day 31. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum | Basel | Switzerland |
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| From day 0 to day 55 |
| Local skin tolerability: other effects score | Summarized statistics of tolerability assessment based on dermal response score and other effects score. The other effects score ranges from score 0 (better, None observed) to score 4 (worse, Glazing with fissures, Film of dried serous exudates covering all or part of the patch site, Small petechial erosions and/or scabs). | From day 0 to day 55 |
| during the procedure, day 0 - day 31 |
| AUC of BAC6027 | Area under the curve (AUC) of the plasma concentration determined. | during the procedure, day 0 - day 31 |
| AUC (0-t), of BAC6027 | Concentration from time zero to the last quantifiable concentration at time t, in case plasma concentration can be determined. | during the procedure, day 0 - day 31 |
| T1/2 of BAC6027 | The plasma elimination half-life, In case plasma concentration can be determined. | during the procedure, day 0 - day 31 |
| AUC (0-∞) of BAC6027 | The AUC of the plasma concentration from time zero to infinity with extrapolation of the terminal phase, In case plasma concentration can be determined. | during the procedure, day 0 - day 31 |