Clinical trial NCT05848453: Safety, Tolerability, and Pharmacokinetics of BAP5191 in Healthy Adults Following Topical Application of Repeat Doses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bacoba AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
name: Swiss TPH, Basel, Switzerland
First posted: 2023-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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.


Eligibility 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.

Primary outcomes:
measure: General safety (number, frequency, severity, seriousness and duration of adverse events)
timeFrame: From day 0 to day 55
measure: Blood pressure from baseline
timeFrame: From day 0 to day 55
measure: Heart rate from baseline
timeFrame: From day 0 to day 55
measure: Respiratory rate from baseline
timeFrame: From day 0 to day 55
measure: Temperature from baseline
timeFrame: From day 0 to day 55
measure: ECG parameters from baseline
timeFrame: From day 0 to day 55
measure: Local skin tolerability: dermal response score
timeFrame: From day 0 to day 55
measure: Local skin tolerability: other effects score
timeFrame: From day 0 to day 55
Secondary outcomes:
measure: Cmax of BAC6027
timeFrame: during the procedure, day 0 - day 31
measure: Tmax of BAC6027
timeFrame: during the procedure, day 0 - day 31
measure: AUC of BAC6027
timeFrame: during the procedure, day 0 - day 31
measure: AUC (0-t), of BAC6027
timeFrame: during the procedure, day 0 - day 31
measure: T1/2 of BAC6027
timeFrame: during the procedure, day 0 - day 31
measure: AUC (0-∞) of BAC6027
timeFrame: during the procedure, day 0 - day 31
Other outcomes:
measure: Histopathological findings of skin biopsies taken after completion of treatment on Day 31.
timeFrame: after the last PK sample collection, Day 31.
Locations:
city: Basel
country: Switzerland
facility: Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum
Study officials:
References: