Healthy Clinical Trial
Official title:
A Phase 1, Double Blind, Randomized, Placebo-Controlled First in Human Study, to Assess the Safety, Tolerability and Pharmacokinetics of BAP5191 Following Topical Application of Repeat Doses in Healthy Adult Participants
Verified date | February 2024 |
Source | Bacoba AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | March 15, 2024 |
Est. primary completion date | March 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum | Basel |
Lead Sponsor | Collaborator |
---|---|
Bacoba AG | Swiss TPH, Basel, Switzerland, University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Primary | 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 | |
Primary | Blood pressure from baseline | Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed. | From day 0 to day 55 | |
Primary | Heart rate from baseline | Change of pulse rate from baseline. | From day 0 to day 55 | |
Primary | Respiratory rate from baseline | Change of respiratory rate from baseline. | From day 0 to day 55 | |
Primary | Temperature from baseline | Change of tympanic temperature from baseline. | From day 0 to day 55 | |
Primary | 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 | |
Primary | 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). | From day 0 to day 55 | |
Primary | 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 | |
Secondary | Cmax of BAC6027 | Peak Plasma Concentration (Cmax) of BAC6027, if detectable. | during the procedure, day 0 - day 31 | |
Secondary | Tmax of BAC6027 | Time to reach Cmax (Tmax), in case of plasma concentration determined. | during the procedure, day 0 - day 31 | |
Secondary | AUC of BAC6027 | Area under the curve (AUC) of the plasma concentration determined. | during the procedure, day 0 - day 31 | |
Secondary | 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 | |
Secondary | T1/2 of BAC6027 | The plasma elimination half-life, In case plasma concentration can be determined. | during the procedure, day 0 - day 31 | |
Secondary | AUC (0-8) 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 |
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