Atopic DermatitisPhase 1NCT05718921
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
A Phase 1 study testing YR001 Dose A on low body surface area, YR001 Dose A on middle body surface area and YR001 Dose A on high body surface area in people with Atopic Dermatitis and Psoriasis, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd at 1 site in United States.
Trial summary
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- What is being tested?
- YR001 Dose A on low body surface area, YR001 Dose A on middle body surface area and YR001 Dose A on high body surface area
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2023to 14 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
About this study
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
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
- Conditions
- Atopic Dermatitis, Psoriasis
- Being tested
- 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
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YR001 Dose A on low body surface areaDrug
Part A: Single topical dose
YR001 Dose A on middle body surface areaDrug
Part A: Single topical dose
YR001 Dose A on high body surface areaDrug
Part A: Single topical dose
YR001 Dose B on low body surface areaDrug
Part A: Single topical dose
YR001 Dose B on middle body surface areaDrug
Part A: Single topical dose
YR001 Dose B on high body surface areaDrug
Part A: Single topical dose
Placebo on low body surface areaDrug
Part A: Single topical dose
Placebo on middle body surface areaDrug
Part A: Single topical dose
Placebo on high body surface areaDrug
Part A: Single topical dose
YR001 Dose A on high body surface area twice dailyDrug
Part B: Multiple topical dose
YR001 Dose B on high body surface area twice dailyDrug
Part B: Multiple topical dose
Placebo on high body surface area twice dailyDrug
Part B: Multiple topical dose
| Study group | Role | What they receive |
|---|---|---|
| Part A, Active dose A and Low body surface area | Experimental | The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration Receives: Drug: YR001 Dose A on low body surface area |
| Part A, Active dose A and Middle body surface area | Experimental | The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration Receives: Drug: YR001 Dose A on middle body surface area |
| Part A, Active dose A and High body surface area | Experimental | The intervention is YR001 Dose A on high body surface area, low dose for single topical administration Receives: Drug: YR001 Dose A on high body surface area |
| Part A, Active dose B and Low body surface area | Experimental | The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration Receives: Drug: YR001 Dose B on low body surface area |
| Part A, Active dose B and Middle body surface area | Experimental | The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration Receives: Drug: YR001 Dose B on middle body surface area |
| Part A, Active dose B and High body surface area | Experimental | The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration Receives: Drug: YR001 Dose B on high body surface area |
| Part A, Placebo and Low body surface area | Placebo comparator | The intervention is Placebo on low body surface area, Placebo for single topical administration Receives: Drug: Placebo on low body surface area |
| Part A, Placebo and Middle body surface area | Placebo comparator | The intervention is Placebo on middle body surface area, Placebo for single topical administration Receives: Drug: Placebo on middle body surface area |
| Part A, Placebo and High body surface area | Placebo comparator | The intervention is Placebo on high body surface area, Placebo for single topical administration Receives: Drug: Placebo on high body surface area |
| Part B, Active dose A and High body surface area | Experimental | The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration Receives: Drug: YR001 Dose A on high body surface area twice daily |
| Part B, Active dose B and High body surface area | Experimental | The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration Receives: Drug: YR001 Dose B on high body surface area twice daily |
| Part B, Placebo and High body surface area | Placebo comparator | The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration Receives: Drug: Placebo on high body surface area twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Measured: day 0 to day 8
Part B: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Measured: day 0 to day 22
Secondary outcomes (2)
Part A: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Measured: day 0 to day 8
Part B: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Measured: day 0 to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Apr 2023
- Primary completion14 Aug 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study includes two sequential parts of single dose and multiple dose with placebo control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacy Smith, Dr. MD, Study director, Encinitas, California USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718921
- Sponsor's protocol ID
- YR001-A01
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05718921
- Acronym / sponsor ID
- YR001-A01
- Conditions
- Atopic Dermatitis, Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
- Model description
- This study includes two sequential parts of single dose and multiple dose with placebo control
| Arm | Type | Receives |
|---|---|---|
| Part A, Active dose A and Low body surface area | Experimental | Drug: YR001 Dose A on low body surface areaThe intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration |
| Part A, Active dose A and Middle body surface area | Experimental | Drug: YR001 Dose A on middle body surface areaThe intervention is YR001 Dose A on middle body surface area, low dose for single topical administration |
| Part A, Active dose A and High body surface area | Experimental | Drug: YR001 Dose A on high body surface areaThe intervention is YR001 Dose A on high body surface area, low dose for single topical administration |
| Part A, Active dose B and Low body surface area | Experimental | Drug: YR001 Dose B on low body surface areaThe intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration |
| Part A, Active dose B and Middle body surface area | Experimental | Drug: YR001 Dose B on middle body surface areaThe intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration |
| Part A, Active dose B and High body surface area | Experimental | Drug: YR001 Dose B on high body surface areaThe intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration |
| Part A, Placebo and Low body surface area | Placebo comparator | Drug: Placebo on low body surface areaThe intervention is Placebo on low body surface area, Placebo for single topical administration |
| Part A, Placebo and Middle body surface area | Placebo comparator | Drug: Placebo on middle body surface areaThe intervention is Placebo on middle body surface area, Placebo for single topical administration |
| Part A, Placebo and High body surface area | Placebo comparator | Drug: Placebo on high body surface areaThe intervention is Placebo on high body surface area, Placebo for single topical administration |
| Part B, Active dose A and High body surface area | Experimental | Drug: YR001 Dose A on high body surface area twice dailyThe intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration |
| Part B, Active dose B and High body surface area | Experimental | Drug: YR001 Dose B on high body surface area twice dailyThe intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration |
| Part B, Placebo and High body surface area | Placebo comparator | Drug: Placebo on high body surface area twice dailyThe intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YR001 Dose A on low body surface areaPart A: Single topical dose | Drug | Part A, Active dose A and Low body surface area |
| YR001 Dose A on middle body surface areaPart A: Single topical dose | Drug | Part A, Active dose A and Middle body surface area |
| YR001 Dose A on high body surface areaPart A: Single topical dose | Drug | Part A, Active dose A and High body surface area |
| YR001 Dose B on low body surface areaPart A: Single topical dose | Drug | Part A, Active dose B and Low body surface area |
| YR001 Dose B on middle body surface areaPart A: Single topical dose | Drug | Part A, Active dose B and Middle body surface area |
| YR001 Dose B on high body surface areaPart A: Single topical dose | Drug | Part A, Active dose B and High body surface area |
| Placebo on low body surface areaPart A: Single topical dose | Drug | Part A, Placebo and Low body surface area |
| Placebo on middle body surface areaPart A: Single topical dose | Drug | Part A, Placebo and Middle body surface area |
| Placebo on high body surface areaPart A: Single topical dose | Drug | Part A, Placebo and High body surface area |
| YR001 Dose A on high body surface area twice dailyPart B: Multiple topical dose | Drug | Part B, Active dose A and High body surface area |
| YR001 Dose B on high body surface area twice dailyPart B: Multiple topical dose | Drug | Part B, Active dose B and High body surface area |
| Placebo on high body surface area twice dailyPart B: Multiple topical dose | Drug | Part B, Placebo and High body surface area |
Primary outcome
Part A: Safety and Maximum Tolerate Dose (MTD)
Time frame: day 0 to day 8
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Part B: Safety and Maximum Tolerate Dose (MTD)
Time frame: day 0 to day 22
Incidence of treatment related AEs (TRAEs) and local skin tolerance
2 secondary outcomes
Part A: all treatment-emergent AEs
Time frame: day 0 to day 8
Part B: all treatment-emergent AEs
Time frame: day 0 to day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Smith, Dr. MD study director
Encinitas, California USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YR001 Dose A on low body surface area, YR001 Dose A on middle body surface area and YR001 Dose A on high body surface area in people with Atopic Dermatitis and Psoriasis, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Safety and Maximum Tolerate Dose (MTD) (time frame: day 0 to day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.