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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05848453
Other study ID # BAP5191-101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 28, 2023
Est. completion date March 15, 2024

Study information

Verified date February 2024
Source Bacoba AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAP5191
Placebo

Locations

Country Name City State
Switzerland Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum Basel

Sponsors (3)

Lead Sponsor Collaborator
Bacoba AG Swiss TPH, Basel, Switzerland, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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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