Safety, Tolerability, and Pharmacokinetics of BAP5191 in Healthy Adults Following Topical Application of Repeat Doses

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BAP5191

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Adams, PhD; Phone Number: +41 (78) 734 0078; Email: adams@bacoba.ch
• Study Contact Backup: Name: Alessandra Zizzari, PhD; Email: zizzari@bacoba.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 1 mg/mL (0.1%) BAC6027 formulation; placebo	Drug: BAP5191; Placebo
Experimental: Cohort 2; 5 mg/mL (0.5%) BAC6027 formulation; placebo	Drug: BAP5191; Placebo
Experimental: Cohort 3; 10 mg/mL (1.0%) BAC6027 formulation; placebo	Drug: BAP5191; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Heart rate from baseline	Change of pulse rate from baseline.	From day 0 to day 55
Respiratory rate from baseline	Change of respiratory rate from baseline.	From day 0 to day 55
Temperature from baseline	Change of tympanic temperature from baseline.	From day 0 to day 55
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
Blood pressure from baseline	Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed.	From day 0 to day 55
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of BAC6027	Peak Plasma Concentration (Cmax) of BAC6027, if detectable.	during the procedure, day 0 - day 31
Tmax of BAC6027	Time to reach Cmax (Tmax), in case of plasma concentration determined.	during the procedure, day 0 - day 31
AUC of BAC6027	Area under the curve (AUC) of the plasma concentration determined.	during the procedure, day 0 - day 31
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
T1/2 of BAC6027	The plasma elimination half-life, In case plasma concentration can be determined.	during the procedure, day 0 - day 31
AUC (0-∞) 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Bacoba AG
• Collaborators: University Hospital, Basel, Switzerland; Swiss TPH, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BAP5191-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No