Study to Evaluate the parameters of TRX-248 Transdermal System in Healthy Female Volunteers

Exclusion Criteria28

• Participation in another clinical study with an investigational product (IP) or device within 60 days or 5 half-lives prior to Screening (days from last dose).
• Plasma donation within 14 days of Screening or any blood donation or blood loss > 500 mL within 30 days of Screening.
• Has skin color or tone that may not allow reliable evaluation of irritation.
• Unwilling to abstain from strenuous physical exercise and from alcohol consumption for 48 hours prior to scheduled PK blood draws at the clinic visits.
• Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms.
• Has cuts, scratches/abrasions, scars, breaks in the skin surface, tattoos at the application sites, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks, moles and/or similar abnormalities at the intended application sites which would affect absorption of the IP.
• Unwilling to refrain from using tanning salons, saunas, or sunbathe during the conduct of the study. Unwilling to also refrain from shaving of application site, waxing of application site, or using lotion hair remover on or near application site from 21 days before TS application and during the conduct of the study.
• Smoke more than 2 cigarettes per day, or vaping equivalent.
• History of or current clinically important disease or disorder, including neurologic, pulmonary, hepatic, renal, metabolic, psychiatric, cardiovascular, gastrointestinal, endocrinologic, immunologic, hematologic, active cancer, clinically important infection, or other abnormality that may interfere with the evaluation or administration of the IP, interpretation of subject safety or study results, or would make participation in the study an unacceptable risk including any significant acute or chronic medical condition. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the Sponsor/Medical Monitor may be warranted. These include but are not limited to:
• Myocardial infarction, hospitalization for unstable angina or arrhythmia, or unexplained syncope within 6 months of Screening.
• Transient Ischemic Attack (TIA) or stroke within 6 months of Screening.
• History of severe allergy/hypersensitivity reactions or ongoing allergy/hypersensitivity reactions, or history of hypersensitivity to treprostinil or other prostacyclin drugs.
• History of allergy with skin reaction is excluded even if not considered clinically significant.
• History of allergy or sensitivity or hypersensitivity to the ingredients in the TS including glues/adhesives, topical alcohol, medical grade adhesive tapes, sunscreens, cosmetics, lotions, fragrances, and/or latex.
• History of allergy, dermatitis or sensitivity or hypersensitivity to band aids, ECG dots, or other adhesive.
• Any medical or surgical procedure or trauma within 28 days of Day 1.
• Clinically significant finding in physical examination, vital signs, ECG or clinical laboratory tests at Screening or Day -1 that could
• affect the subject’s safety or ability to complete the study, as judged by the Investigator.
• Hemoglobin < 110 g/L.
• Blood pressure: Systolic value 140/90 mmHg.
• AST (aspartate transaminase) or ALT (alanine transaminase) levels > 1.5 upper limit of normal (ULN).
• Creatinine clearance of < lower limit of normal (LLN) as determined by the Cockcroft-Gault formula.
• Positive pregnancy test at Screening or between Screening and randomization (fertile females only).
• Heart rate is less than or equal to 40 bpm.
• Assessment may be repeated once for eligibility determination at Screening or Day -1.
• Use of any topical medication in the areas intended for TS application within 14 days prior to the first TS application and throughout the study.
• Use of any topical products with or without medicinal ingredient (including but not limited to perfumes, body lotions, sunscreens, spray or TS oils, creams and alcohol) on the sites intended for TS application within 48 hours prior to the first TS application and throughout the study. Topical application of products without significant systemic absorption are allowed in areas other than the ones intended for TS application. Sponsor to be consulted with any questions.
• Non-metastatic basal cell carcinoma of the skin, completely resected squamous skin cancer with no recurrence for 12 months, carcinoma in situ of the cervix may be enrolled with prior approval from Corsair.