Clinical trial NCT05718921: A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Psoriasis
Lead sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study includes two sequential parts of single dose and multiple dose with placebo control
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained from the subject
2. Male or female subject is aged between 18 and 65 years
3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2
4. 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

Exclusion Criteria:

1. 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.
2. Pregnant or lactating women.
3. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
4. 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.
5. Have active infectious disease.
6. Subjects treated with another investigational drug, biological agent, or device
7. Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
8. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
9. Active untreated mental or psychiatric disorder.
10. Any major surgery within 6 months of screening.
11. 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.

Primary outcomes:
measure: Part A: Safety and Maximum Tolerate Dose (MTD)
timeFrame: day 0 to day 8
measure: Part B: Safety and Maximum Tolerate Dose (MTD)
timeFrame: day 0 to day 22
Secondary outcomes:
measure: Part A: all treatment-emergent AEs
timeFrame: day 0 to day 8
measure: Part B: all treatment-emergent AEs
timeFrame: day 0 to day 22
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
Study officials:
affiliation: Encinitas, California USA
name: Stacy Smith, Dr. MD
role: STUDY_DIRECTOR
References: