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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Drug: YR001 Dose A on low body surface area; Drug: YR001 Dose A on middle body surface area; Drug: YR001 Dose A on high body surface area; Drug: YR001 Dose B on low body surface area; Drug: YR001 Dose B on middle body surface area; Drug: YR001 Dose B on high body surface area; Drug: Placebo on low body surface area; Drug: Placebo on middle body surface area; Drug: Placebo on high body surface area; Drug: YR001 Dose A on high body surface area twice daily; Drug: YR001 Dose B on high body surface area twice daily; Drug: Placebo on high body surface area twice daily

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Active dose A and Low body surface area; The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration	Drug: YR001 Dose A on low body surface area; Part A: Single topical dose
Experimental: Part A, Active dose A and Middle body surface area; The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration	Drug: YR001 Dose A on middle body surface area; Part A: Single topical dose
Experimental: Part A, Active dose A and High body surface area; The intervention is YR001 Dose A on high body surface area, low dose for single topical administration	Drug: YR001 Dose A on high body surface area; Part A: Single topical dose
Experimental: Part A, Active dose B and Low body surface area; The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration	Drug: YR001 Dose B on low body surface area; Part A: Single topical dose
Experimental: Part A, Active dose B and Middle body surface area; The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration	Drug: YR001 Dose B on middle body surface area; Part A: Single topical dose
Experimental: Part A, Active dose B and High body surface area; The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration	Drug: YR001 Dose B on high body surface area; Part A: Single topical dose
Placebo Comparator: Part A, Placebo and Low body surface area; The intervention is Placebo on low body surface area, Placebo for single topical administration	Drug: Placebo on low body surface area; Part A: Single topical dose
Placebo Comparator: Part A, Placebo and Middle body surface area; The intervention is Placebo on middle body surface area, Placebo for single topical administration	Drug: Placebo on middle body surface area; Part A: Single topical dose
Placebo Comparator: Part A, Placebo and High body surface area; The intervention is Placebo on high body surface area, Placebo for single topical administration	Drug: Placebo on high body surface area; Part A: Single topical dose
Experimental: Part B, Active dose A and High body surface area; The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration	Drug: YR001 Dose A on high body surface area twice daily; Part B: Multiple topical dose
Experimental: Part B, Active dose B and High body surface area; The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration	Drug: YR001 Dose B on high body surface area twice daily; Part B: Multiple topical dose
Placebo Comparator: Part B, Placebo and High body surface area; The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration	Drug: Placebo on high body surface area twice daily; Part B: Multiple topical dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Safety and Maximum Tolerate Dose (MTD)	Incidence of treatment related AEs (TRAEs) and local skin tolerance	day 0 to day 8
Part B: Safety and Maximum Tolerate Dose (MTD)	Incidence of treatment related AEs (TRAEs) and local skin tolerance	day 0 to day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: all treatment-emergent AEs	Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)	day 0 to day 8
Part B: all treatment-emergent AEs	Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)	day 0 to day 22

Collaborators and Investigators

• Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
• Investigators: Study Director: Stacy Smith, Dr. MD, Encinitas, California USA

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2023
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatitis
• Other Study ID Numbers: YR001-A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No