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Tests treatment safety and results for Health Adult Subjects
Official title 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
ClinicalTrials.gov ID: NCT07673458
What this study is testing
What is PA032?
PA032 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for health adult subjects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Female participants of childbearing potential and all male participants must agree to use effective contraceptive methods during the study and for 3...
You likely can't join if
- Current or history of clinically significant medical conditions or other disorders that may interfere with the assessment of safety, side effects, or...
- 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...
- Dermatological diseases or infections (e.g., acne, impetigo) or skin conditions at the intended application area that may interfere with study...
- 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...
See the full eligibility criteria
- 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...
- Willing and able to comply with scheduled study visits, treatment administration, laboratory tests, and other study procedures.
- Current or history of clinically significant medical conditions or other disorders that may interfere with the assessment of safety, side effects, 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...
- 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...
- 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).
- Existing renal impairment as judged by the investigator.
- Existing hepatic impairment as judged by the investigator.
- Participation in another treatment 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...
- 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...
- 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...
- 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...
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Langfang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Langfang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.