A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects

This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Selegiline transdermal system in comparison to EMSAM® transdermal patch in healthy volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.

Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.

Inclusion criteria

• Male or female non-smoking subject.
• Lack of clinically significant abnormalities in health assessments performed at screening as deemed by the Investigator (or designee)
• BMI within the range (including the borders) of 18.5 to 29.9 kg/m2

Exclusion criteria

• Medical history or presence of ANY current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study
• Medical history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, seizure disorders, or cardiovascular disorders (especially hypertension or family history of sudden cardiac death)
• Medical history of a condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as HIV or AIDS; allergic diseases such as anaphylaxis, asthma, or generalized drug reaction; neoplasms such as lymphoma or leukemia; rheumatoid arthritis; or systemic lupus erythematosus)
• Clinically significant illness within 4 weeks before screening visit