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

Completed · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis, Psoriasis

In brief

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.

Key facts

Study ID

NCT05718921

Run by

Hangzhou Yirui Pharmaceutical Technology Co., Ltd

People needed

54

Starts

2023-04-08

Expected to finish

2023-12-14

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Pregnant or lactating women.
• Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
• 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.
• Have active infectious disease.
• 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.
• Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
• Active untreated mental or psychiatric disorder.
• Any major surgery within 6 months of screening.
• 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.
• Drug or alcohol abuse history.

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States

Full record on ClinicalTrials.gov

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