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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

NCT00002811

Precancerous Condition

UNKNOWN PHASE3

DMT310-005 Topical in the Treatment of Acne Rosacea

NCT05108025

Acne Rosacea

UNKNOWN PHASE2

Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

NCT00544258

Actinic Keratoses

COMPLETED PHASE1

To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

NCT04476043

Hidradenitis Suppurativa Acne Inversa

COMPLETED PHASE2

Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel

NCT00239135

Keratosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

1 mg/mL (0.1%) BAC6027 formulation; placebo

Group Type EXPERIMENTAL

BAP5191

Intervention Type DRUG

Placebo

Cohort 2

5 mg/mL (0.5%) BAC6027 formulation; placebo

Group Type EXPERIMENTAL

BAP5191

Intervention Type DRUG

Placebo

Cohort 3

10 mg/mL (1.0%) BAC6027 formulation; placebo

Group Type EXPERIMENTAL

BAP5191

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAP5191

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes