A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers

Korábbi kezelés

• Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
• Subjects treated with another investigational drug, biological agent, or device
• Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
• Any major surgery within 6 months of screening.
• Drug or alcohol abuse history.

Más betegség

• Presence or history of a clinically significant medical condition or other condition that might interfere with the safety, tolerability and PK assessment of ointment YR001, or place the subject at an unacceptable risk as a subject in this study.
• Have active infectious disease.
• Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
• Active untreated mental or psychiatric disorder.
• Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.

Egyéb

• Pregnant or lactating women.
• Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.

• Written informed consent obtained from the subject
• Male or female subject is aged between 18 and 65 years
• Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2
• Free from any clinically relevant illness or disease incl. skin disorder that may adversely affect the safety of the subject or the integrity of the study