Health Adult SubjectsPhase 1NCT07673458
An Early-stage Clinical Trial to Evaluate the Safety, Absorption, and Disposition of YR001 Ointment Following Topical Application on the Skin of Healthy Chinese Subjects
A Phase 1 study testing PA032 in people with Health Adult Subjects, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, local tolerability, and pharmacokinetic (PK) profile of YR001 Topical Ointment in healthy Chinese participants. This is a first-in-China, Phase I study designed to assess the drug's systemic absorption and disposition following single and multiple topical… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- PA032
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 11 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Voluntarily sign the informed consent form to participate in the study.
- Male or female, aged 18 to 65 years (inclusive).
- Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m² (inclusive).
- Skin at the intended application area is intact without ulceration, injury, sunburn, redness, rash, or other abnormalities at screening and prior to dosing.
- Female participants of childbearing potential and all male participants must agree to use effective contraceptive methods during the study and for 3 months after the last dose.
- No clinically relevant diseases, including dermatological conditions, as determined by medical history, physical examination, safety laboratory tests, and other assessments, that could adversely affect participant safety or study integrity or interfere with study results.
- Willing and able to comply with scheduled study visits, treatment administration, laboratory tests, and other study procedures.
Who cannot join
- Current or history of clinically significant medical conditions or other disorders that may interfere with the assessment of safety, tolerability, or PK of YR001 Ointment, or place the participant at increased risk.
- Pregnant or breastfeeding women, or participants with a positive pregnancy test.
- Tattoos, scars, cuts, bruises, or other skin injuries (including excessive UV exposure) at the intended application site that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, excretion, or trial safety.
- Dermatological diseases or infections (e.g., acne, impetigo) or skin conditions at the intended application area that may interfere with study assessments, or that the investigator considers may affect drug absorption or skin observation.
- Unwilling to refrain from using depilatory creams or wax on the intended application area for 2 weeks prior to dosing and throughout the study.
- Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus IgG antibody (Anti-HCV), Treponema pallidum antibody (Anti-TP), or human immunodeficiency virus antibody (Anti-HIV).
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- Existing renal impairment as judged by the investigator.
- Existing hepatic impairment as judged by the investigator.
- Participation in another interventional clinical trial (e.g., investigational drug, biologic, or device) within 90 days prior to baseline, or currently in the follow-up period of another study, or prior participation in this clinical trial.
- Use of any over-the-counter (OTC) or prescription medications (including probiotics/prebiotics, vitamins, herbal supplements, and nutraceuticals, with the exception of acetaminophen/paracetamol) within 14 days prior to baseline, or receipt of vaccination within this period.
- Currently diagnosed with acute or chronic inflammatory diseases (limited to autoimmune diseases and infectious diseases, e.g., tuberculosis). Participants whose disease symptoms have resolved for ≥ 12 months without any treatment may be considered in remission and eligible for enrollment.
- Use of topical skin products (including emollients) at the intended application site within 48 hours prior to baseline; use of topical products on non-application sites is permitted.
- Clinically significant cardiac conduction abnormalities on electrocardiogram (ECG) as judged by the study physician.
- Known allergy to the active substance or any excipient of the ointment.
- Any major surgery within 6 months prior to the screening period.
- Diagnosis of malignancy within 5 years prior to screening, with the exception of successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Employees of the sponsor, clinical service organization, or clinical research site.
- History of drug abuse or substance use disorder within the past year; history of alcoholism within the past 6 months (as judged by the investigator); smoking > 5 cigarettes per day within the past 3 months, or inability to refrain from smoking during the study.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hebei CNPC Central Hospital
Langfang, Hebei, 065000
kexin zhao, 086-13582771223, cnpcgcp@163.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR001 Topical Ointment in Healthy Chinese Participants: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study.
The goal of this clinical trial is to evaluate the safety, local tolerability, and pharmacokinetic (PK) profile of YR001 Topical Ointment in healthy Chinese participants. This is a first-in-China, Phase I study designed to assess the drug's systemic absorption and disposition following single and multiple topical applications.
The main questions it aims to answer are:
Read more
What is the safety and local tolerability profile of YR001 Topical Ointment after single-dose and multiple-dose administration in healthy Chinese participants?
What are the pharmacokinetic characteristics (e.g., plasma drug concentrations) of YR001 Topical Ointment after single and multiple topical applications?
Researchers will compare participants receiving YR001 Topical Ointment with participants receiving vehicle (placebo) to determine whether the safety profile and local tolerability of YR001 are comparable to placebo.
Participants will:
Receive topical application of either YR001 Topical Ointment or matching placebo (vehicle) on approximately 10% or 20% of their body surface area, depending on the assigned group
Undergo serial blood sampling for pharmacokinetic assessments at specified time points before and after drug administration
Complete safety evaluations including physical examinations, vital signs, laboratory tests (hematology, biochemistry, coagulation, thyroid function, urinalysis), 12-lead ECGs, and local tolerability assessments at the application site
Remain in the clinical unit for specified periods during the dosing and follow-up phases, with total study participation duration up to approximately 30 days per participant
- Conditions
- Health Adult Subjects
- Being tested
- PA032, Vehicle Ointment
- Keywords
- Phase 1, Double-Blind, Safety and Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA032Drug
YR001 ointment containing 2% PA032 (Kv1.3 potassium channel blocker) for topical application
Vehicle OintmentDrug
Matching vehicle ointment without active ingredient (identical appearance, packaging, and administration)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SAD-MAD (20% BSA, BID) | Experimental | Single topical application of YR001 ointment or placebo at approximately 20% BSA on Day 1, followed by multiple-dose administration (twice daily from Day 3 to Day 8, once on Day 9 morning) if safety is acceptable. Receives: Drug: PA032; Drug: Vehicle Ointment |
| Group 2: MAD (10% BSA, BID) | Experimental | Multiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, twice daily from Day 1 to Day 6, and once on Day 7 morning. Receives: Drug: PA032; Drug: Vehicle Ointment |
| Group 3: MAD (20% BSA, TID) | Experimental | Multiple-dose topical administration of YR001 ointment or placebo at approximately 20% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning. Receives: Drug: PA032; Drug: Vehicle Ointment |
| Group 4: MAD (10% BSA, TID) | Experimental | Multiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning. Receives: Drug: PA032; Drug: Vehicle Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of YR001 Ointment: Incidence of Adverse Events
Number of participants with adverse events (AEs), drug-related adverse events (DRAEs), serious adverse events (SAEs), and adverse events leading to study discontinuation, as assessed by CTCAE v6.0.
Measured: From signing of informed consent through 7 days after the last dose (up to approximately 30 days for Group 1; up to 21 days for Groups 2-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start22 Jun 2026
- Primary completion18 Sep 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673458
- Sponsor's protocol ID
- YR001-A02
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR001 Topical Ointment in Healthy Chinese Participants: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study.
- ClinicalTrials.gov ID
- NCT07673458
- Acronym / sponsor ID
- YR001-A02
- Conditions
- Health Adult Subjects
- Keywords
- Phase 1, Double-Blind, Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 29 Jun 2026 (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.
The goal of this clinical trial is to evaluate the safety, local tolerability, and pharmacokinetic (PK) profile of YR001 Topical Ointment in healthy Chinese participants. This is a first-in-China, Phase I study designed to assess the drug's systemic absorption and disposition following single and multiple topical applications.
The main questions it aims to answer are:
What is the safety and local tolerability profile of YR001 Topical Ointment after single-dose and multiple-dose administration in healthy Chinese participants?
What are the pharmacokinetic characteristics (e.g., plasma drug concentrations) of YR001 Topical Ointment after single and multiple topical applications?
Researchers will compare participants receiving YR001 Topical Ointment with participants receiving vehicle (placebo) to determine whether the safety profile and local tolerability of YR001 are comparable to placebo.
Participants will:
Receive topical application of either YR001 Topical Ointment or matching placebo (vehicle) on approximately 10% or 20% of their body surface area, depending on the assigned group
Undergo serial blood sampling for pharmacokinetic assessments at specified time points before and after drug administration
Complete safety evaluations including physical examinations, vital signs, laboratory tests (hematology, biochemistry, coagulation, thyroid function, urinalysis), 12-lead ECGs, and local tolerability assessments at the application site
Remain in the clinical unit for specified periods during the dosing and follow-up phases, with total study participation duration up to approximately 30 days per participant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: SAD-MAD (20% BSA, BID) | Experimental | Drug: PA032, Drug: Vehicle OintmentSingle topical application of YR001 ointment or placebo at approximately 20% BSA on Day 1, followed by multiple-dose administration (twice daily from Day 3 to Day 8, once on Day 9 morning) if safety is acceptable. |
| Group 2: MAD (10% BSA, BID) | Experimental | Drug: PA032, Drug: Vehicle OintmentMultiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, twice daily from Day 1 to Day 6, and once on Day 7 morning. |
| Group 3: MAD (20% BSA, TID) | Experimental | Drug: PA032, Drug: Vehicle OintmentMultiple-dose topical administration of YR001 ointment or placebo at approximately 20% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning. |
| Group 4: MAD (10% BSA, TID) | Experimental | Drug: PA032, Drug: Vehicle OintmentMultiple-dose topical administration of YR001 ointment or placebo at approximately 10% BSA, three times daily from Day 1 to Day 6, and once on Day 7 morning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign the informed consent form to participate in the study.
- Male or female, aged 18 to 65 years (inclusive).
- Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m² (inclusive).
- Skin at the intended application area is intact without ulceration, injury, sunburn, redness, rash, or other abnormalities at screening and prior to dosing.
- Female participants of childbearing potential and all male participants must agree to use effective contraceptive methods during the study and for 3 months after the last dose.
Key exclusion criteria (19 listed)
- Current or history of clinically significant medical conditions or other disorders that may interfere with the assessment of safety, tolerability, or PK of YR001 Ointment, or place the participant at increased risk.
- Pregnant or breastfeeding women, or participants with a positive pregnancy test.
- Tattoos, scars, cuts, bruises, or other skin injuries (including excessive UV exposure) at the intended application site that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, excretion, or trial safety.
- Dermatological diseases or infections (e.g., acne, impetigo) or skin conditions at the intended application area that may interfere with study assessments, or that the investigator considers may affect drug absorption or skin observation.
- Unwilling to refrain from using depilatory creams or wax on the intended application area for 2 weeks prior to dosing and throughout the study.
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 |
|---|---|---|
| PA032YR001 ointment containing 2% PA032 (Kv1.3 potassium channel blocker) for topical application | Drug | Group 1: SAD-MAD (20% BSA, BID), Group 2: MAD (10% BSA, BID), Group 3: MAD (20% BSA, TID), Group 4: MAD (10% BSA, TID) |
| Vehicle OintmentMatching vehicle ointment without active ingredient (identical appearance, packaging, and administration) | Drug | Group 1: SAD-MAD (20% BSA, BID), Group 2: MAD (10% BSA, BID), Group 3: MAD (20% BSA, TID), Group 4: MAD (10% BSA, TID) |
Primary outcome
Safety and Tolerability of YR001 Ointment: Incidence of Adverse Events
Time frame: From signing of informed consent through 7 days after the last dose (up to approximately 30 days for Group 1; up to 21 days for Groups 2-4)
Number of participants with adverse events (AEs), drug-related adverse events (DRAEs), serious adverse events (SAEs), and adverse events leading to study discontinuation, as assessed by CTCAE v6.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 PA032 in people with Health Adult Subjects, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd at 1 site in China.
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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jiawei wang (086-13989498498, jiawei.wang@yirui-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of YR001 Ointment: Incidence of Adverse Events (time frame: From signing of informed consent through 7 days after the last dose (up to approximately 30 days for Group 1; up to 21 days for Groups 2-4)). 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 1 Jul 2026.