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Topical Ointment
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 22
Summary
This trial is testing a special skin cream called YR001 on healthy adults to see if it is safe, well-tolerated, and how it behaves in the body.
Eligible Conditions
- Psoriasis
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 22
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 22
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Safety and Maximum Tolerate Dose (MTD)
Part B: Safety and Maximum Tolerate Dose (MTD)
Secondary study objectives
Part A: all treatment-emergent AEs
Part B: all treatment-emergent AEs
Trial Design
12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B, Active dose B and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration
Group II: Part B, Active dose A and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration
Group III: Part A, Active dose B and Middle body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration
Group IV: Part A, Active dose B and Low body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration
Group V: Part A, Active dose B and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration
Group VI: Part A, Active dose A and Middle body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration
Group VII: Part A, Active dose A and Low body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration
Group VIII: Part A, Active dose A and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on high body surface area, low dose for single topical administration
Group IX: Part A, Placebo and Low body surface areaPlacebo Group1 Intervention
The intervention is Placebo on low body surface area, Placebo for single topical administration
Group X: Part A, Placebo and Middle body surface areaPlacebo Group1 Intervention
The intervention is Placebo on middle body surface area, Placebo for single topical administration
Group XI: Part A, Placebo and High body surface areaPlacebo Group1 Intervention
The intervention is Placebo on high body surface area, Placebo for single topical administration
Group XII: Part B, Placebo and High body surface areaPlacebo Group1 Intervention
The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YR001 Dose A on low body surface area
2023
Completed Phase 1
~60
YR001 Dose A on middle body surface area
2023
Completed Phase 1
~60
YR001 Dose A on high body surface area
2023
Completed Phase 1
~60
YR001 Dose B on low body surface area
2023
Completed Phase 1
~60
YR001 Dose B on middle body surface area
2023
Completed Phase 1
~60
YR001 Dose B on high body surface area
2023
Completed Phase 1
~60
YR001 Dose A on high body surface area twice daily
2023
Completed Phase 1
~60
YR001 Dose B on high body surface area twice daily
2023
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Hangzhou Yirui Pharmaceutical Technology Co., LtdLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Stacy Smith, Dr. MDStudy DirectorEncinitas, California USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Part A, Active dose A and Low body surface area
- Group 2: Part A, Active dose A and Middle body surface area
- Group 3: Part A, Active dose A and High body surface area
- Group 4: Part A, Active dose B and Low body surface area
- Group 5: Part A, Active dose B and Middle body surface area
- Group 6: Part A, Active dose B and High body surface area
- Group 7: Part A, Placebo and Low body surface area
- Group 8: Part A, Placebo and Middle body surface area
- Group 9: Part A, Placebo and High body surface area
- Group 10: Part B, Active dose A and High body surface area
- Group 11: Part B, Active dose B and High body surface area
- Group 12: Part B, Placebo and High body surface area
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.