Healthy
Conditions
Brief summary
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.
Interventions
DRUGBAP5191
Placebo
Sponsors
University Hospital, Basel, Switzerland
Swiss TPH, Basel, Switzerland
Bacoba AG
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy adult participants,18 to 65 years of age. * Women of childbearing potential (WOCBP) must agree to use a highly effective form of contraception, from at least 7 days prior to first administration to 28 days after last administration. * Male participants with WOCBP partner must be willing to use condoms from first IMP application to 90 days after last application. * Body Mass Index (BMI) between 18 and 29.9 kg/m2. Body weight must be greater than 50 kg. * Clinical laboratory parameters, vital signs, pulse oximetry, and ECG within the reference range from population studies, or showing no clinically relevant deviations. Key
Exclusion criteria
* Chronic use of immunosuppressants within 3 years prior to the first administration of the study drug. * History of prior leishmaniasis or extensive travel to endemic regions within 1 year prior to the first administration of the study drug. * Presence or history of severe adverse reaction to any drug, or sensitivity to components of the study medication or to adhesive bandages or tape. * Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application and skin assessment at the site of application.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local skin tolerability: other effects score | From day 0 to day 55 | 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). |
| General safety (number, frequency, severity, seriousness and duration of adverse events) | From day 0 to day 55 | Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events. |
| Blood pressure from baseline | From day 0 to day 55 | Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed. |
| Heart rate from baseline | From day 0 to day 55 | Change of pulse rate from baseline. |
| Respiratory rate from baseline | From day 0 to day 55 | Change of respiratory rate from baseline. |
| Temperature from baseline | From day 0 to day 55 | Change of tympanic temperature from baseline. |
| ECG parameters from baseline | From day 0 to day 55 | Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline. |
| Local skin tolerability: dermal response score | From day 0 to day 55 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of BAC6027 | during the procedure, day 0 - day 31 | Peak Plasma Concentration (Cmax) of BAC6027, if detectable. |
| Tmax of BAC6027 | during the procedure, day 0 - day 31 | Time to reach Cmax (Tmax), in case of plasma concentration determined. |
| AUC of BAC6027 | during the procedure, day 0 - day 31 | Area under the curve (AUC) of the plasma concentration determined. |
| AUC (0-t), of BAC6027 | during the procedure, day 0 - day 31 | Concentration from time zero to the last quantifiable concentration at time t, in case plasma concentration can be determined. |
| T1/2 of BAC6027 | during the procedure, day 0 - day 31 | The plasma elimination half-life, In case plasma concentration can be determined. |
| AUC (0-∞) of BAC6027 | during the procedure, day 0 - day 31 | The AUC of the plasma concentration from time zero to infinity with extrapolation of the terminal phase, In case plasma concentration can be determined. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Histopathological findings of skin biopsies taken after completion of treatment on Day 31. | after the last PK sample collection, Day 31. | Description of histopathological observations by application site and dose administered. |
Countries
Switzerland
Outcome results
None listed