NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Inclusion criteria

• Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
• Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration

Exclusion criteria

• Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
• Laser or surgery at the gel application site within 2 weeks before the gel application.
• Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
• History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
• Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration
• Positive pregnancy test at screening
• Breast-feeding subject
• History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening
• Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection
• Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration