Safety, Tolerability, and Pharmacokinetics of BAP5191 in Healthy Adults Following Topical Application of Repeat Doses
- Registration Number
- NCT05848453
- Lead Sponsor
- Bacoba AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 2 BAP5191 5 mg/mL (0.5%) BAC6027 formulation; placebo Cohort 3 BAP5191 10 mg/mL (1.0%) BAC6027 formulation; placebo Cohort 1 BAP5191 1 mg/mL (0.1%) BAC6027 formulation; placebo
- Primary Outcome Measures
Name Time Method 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).
Blood pressure from baseline From day 0 to day 55 Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
T1/2 of BAC6027 during the procedure, day 0 - day 31 The plasma elimination half-life, In case plasma concentration can be determined.
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 (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.
AUC of BAC6027 during the procedure, day 0 - day 31 Area under the curve (AUC) of the plasma concentration determined.
Trial Locations
- Locations (1)
Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum
🇨🇭Basel, Switzerland