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

Primary Purpose

Atopic Dermatitis, Psoriasis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
YR001 Dose A on low body surface area
YR001 Dose A on middle body surface area
YR001 Dose A on high body surface area
YR001 Dose B on low body surface area
YR001 Dose B on middle body surface area
YR001 Dose B on high body surface area
Placebo on low body surface area
Placebo on middle body surface area
Placebo on high body surface area
YR001 Dose A on high body surface area twice daily
YR001 Dose B on high body surface area twice daily
Placebo on high body surface area twice daily
Sponsored by
Hangzhou Yirui Pharmaceutical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 13. Drug or alcohol abuse history.

Sites / Locations

  • California Dermatology & Clinical Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Part A, Active dose A and Low body surface area

Part A, Active dose A and Middle body surface area

Part A, Active dose A and High body surface area

Part A, Active dose B and Low body surface area

Part A, Active dose B and Middle body surface area

Part A, Active dose B and High body surface area

Part A, Placebo and Low body surface area

Part A, Placebo and Middle body surface area

Part A, Placebo and High body surface area

Part B, Active dose A and High body surface area

Part B, Active dose B and High body surface area

Part B, Placebo and High body surface area

Arm Description

The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration

The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration

The intervention is YR001 Dose A on high body surface area, low dose for single topical administration

The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration

The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration

The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration

The intervention is Placebo on low body surface area, Placebo for single topical administration

The intervention is Placebo on middle body surface area, Placebo for single topical administration

The intervention is Placebo on high body surface area, Placebo for single topical administration

The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration

The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration

The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration

Outcomes

Primary Outcome Measures

Part A: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Part B: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance

Secondary Outcome Measures

Part A: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Part B: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)

Full Information

First Posted
January 30, 2023
Last Updated
May 24, 2023
Sponsor
Hangzhou Yirui Pharmaceutical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05718921
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Yirui Pharmaceutical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This study includes two sequential parts of single dose and multiple dose with placebo control
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A, Active dose A and Low body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration
Arm Title
Part A, Active dose A and Middle body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration
Arm Title
Part A, Active dose A and High body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose A on high body surface area, low dose for single topical administration
Arm Title
Part A, Active dose B and Low body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration
Arm Title
Part A, Active dose B and Middle body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration
Arm Title
Part A, Active dose B and High body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration
Arm Title
Part A, Placebo and Low body surface area
Arm Type
Placebo Comparator
Arm Description
The intervention is Placebo on low body surface area, Placebo for single topical administration
Arm Title
Part A, Placebo and Middle body surface area
Arm Type
Placebo Comparator
Arm Description
The intervention is Placebo on middle body surface area, Placebo for single topical administration
Arm Title
Part A, Placebo and High body surface area
Arm Type
Placebo Comparator
Arm Description
The intervention is Placebo on high body surface area, Placebo for single topical administration
Arm Title
Part B, Active dose A and High body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration
Arm Title
Part B, Active dose B and High body surface area
Arm Type
Experimental
Arm Description
The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration
Arm Title
Part B, Placebo and High body surface area
Arm Type
Placebo Comparator
Arm Description
The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration
Intervention Type
Drug
Intervention Name(s)
YR001 Dose A on low body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose A on middle body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose A on high body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose B on low body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose B on middle body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose B on high body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
Placebo on low body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
Placebo on middle body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
Placebo on high body surface area
Intervention Description
Part A: Single topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose A on high body surface area twice daily
Intervention Description
Part B: Multiple topical dose
Intervention Type
Drug
Intervention Name(s)
YR001 Dose B on high body surface area twice daily
Intervention Description
Part B: Multiple topical dose
Intervention Type
Drug
Intervention Name(s)
Placebo on high body surface area twice daily
Intervention Description
Part B: Multiple topical dose
Primary Outcome Measure Information:
Title
Part A: Safety and Maximum Tolerate Dose (MTD)
Description
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Time Frame
day 0 to day 8
Title
Part B: Safety and Maximum Tolerate Dose (MTD)
Description
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Time Frame
day 0 to day 22
Secondary Outcome Measure Information:
Title
Part A: all treatment-emergent AEs
Description
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Time Frame
day 0 to day 8
Title
Part B: all treatment-emergent AEs
Description
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Time Frame
day 0 to day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 13. Drug or alcohol abuse history.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Wu
Phone
+8619357606325
Email
Lili.wu@yirui-pharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefei Zhou, Dr.
Phone
+8619357606325
Email
xuefei.zhou@yirui-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Smith, Dr. MD
Organizational Affiliation
Encinitas, California USA
Official's Role
Study Director
Facility Information:
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Smith, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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