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OpenTrials
Completed

NCT Number: NCT05848453

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universität Basel Departement Klinische Forschung Ambulantes Studienzentrum

Basel, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAP5191

Drug

Placebo

Primary outcomes

  1. General safety (number, frequency, severity, seriousness and duration of adverse events)

    Time frame: 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.

  2. Blood pressure from baseline

    Time frame: From day 0 to day 55

    Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed.

  3. Heart rate from baseline

    Time frame: From day 0 to day 55

    Change of pulse rate from baseline.

  4. Respiratory rate from baseline

    Time frame: From day 0 to day 55

    Change of respiratory rate from baseline.

  5. Temperature from baseline

    Time frame: From day 0 to day 55

    Change of tympanic temperature from baseline.

  6. ECG parameters from baseline

    Time frame: From day 0 to day 55

    Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline.

  7. Local skin tolerability: dermal response score

    Time frame: 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).

  8. Local skin tolerability: other effects score

    Time frame: 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).

Secondary outcomes

  1. Cmax of BAC6027

    Time frame: during the procedure, day 0 - day 31

    Peak Plasma Concentration (Cmax) of BAC6027, if detectable.

  2. Tmax of BAC6027

    Time frame: during the procedure, day 0 - day 31

    Time to reach Cmax (Tmax), in case of plasma concentration determined.

  3. AUC of BAC6027

    Time frame: during the procedure, day 0 - day 31

    Area under the curve (AUC) of the plasma concentration determined.

  4. AUC (0-t), of BAC6027

    Time frame: 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.

  5. T1/2 of BAC6027

    Time frame: during the procedure, day 0 - day 31

    The plasma elimination half-life, In case plasma concentration can be determined.

  6. AUC (0-∞) of BAC6027

    Time frame: 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.

Other outcomes

  1. Histopathological findings of skin biopsies taken after completion of treatment on Day 31.

    Time frame: after the last PK sample collection, Day 31.

    Description of histopathological observations by application site and dose administered.

Sponsors and collaborators

Lead sponsor

Bacoba AG

Industry

Collaborators

  • Swiss TPH, Basel, Switzerland
  • University Hospital, Basel, Switzerland

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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