NCT05718921CompletedPhase 1
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
A Randomized, Double-blind, Placebo-controlled Single and Multiple Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Topical Ointment YR001 in Adult Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 24 Jan 2024
Brief summary (registry, in English)
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 30 Jan 2023
- Start date
- Apr 2023
- Primary completion date
- Aug 2023
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
- Diseases
- Atopic dermatitis (eczema), Psoriasis
- NCT number
- NCT05718921
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 54
- From Apr 2023 to the primary completion date, Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 13\. Drug or alcohol abuse history.
Other
- Pregnant or lactating women.
- Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| California Dermatology & Clinical Research Institute Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.