YR001 Ointment for Healthy Volunteers

Overseen By Xuefei Zhou, Dr.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Disqualifiers: Pregnancy, Skin disease, Mental disorder, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and metabolism of a new topical ointment called YR001. Researchers will apply the ointment at varying doses and body surface areas to assess its tolerance and absorption. They seek adults who are generally healthy and free from skin conditions that could affect the results. Those without skin issues and who maintain a healthy lifestyle may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a significant medical condition or are taking other investigational drugs, you may not be eligible to participate.

Is there any evidence suggesting that YR001 topical ointment is likely to be safe for humans?

Research has shown that YR001 was safe and well-tolerated in earlier studies. Participants using the YR001 skin ointment did not report any major side effects, indicating general safety. The ointment is currently undergoing tests to determine its effects on the body and its safety for the skin. Although this trial is still in the early stages, the safe use of YR001 in other studies is a positive indicator for its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

YR001 is unique because it offers a topical approach, potentially reducing systemic side effects often seen with oral medications. Unlike traditional treatments that require ingestion or injection, YR001 is applied directly to the skin, which might make it more convenient and less invasive for patients. Researchers are particularly excited about the ability to precisely adjust the dosage and application area, tailoring the treatment to individual needs and possibly enhancing its effectiveness while minimizing side effects.

What evidence suggests that this trial's treatments could be effective?

Research has shown that YR001 is under study for its potential benefits in treating skin conditions. This trial will evaluate various doses and applications of YR001, designed for direct skin application. Early studies have examined its safety and the body's processing of it. Although detailed information on its effectiveness in people remains limited, YR001 may help by targeting specific skin areas to reduce inflammation and irritation. Initial tests in similar conditions have shown promising signs of symptom improvement. Further research is necessary to confirm its potential benefits. ^{3 4 6 7 8}

Who Is on the Research Team?

Stacy Smith, Dr. MD

Principal Investigator

Encinitas, California USA

Are You a Good Fit for This Trial?

Inclusion Criteria

Written informed consent obtained from the subject

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

Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2

Exclusion Criteria

Have active infectious disease

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Part A

Participants receive a single topical administration of YR001 or placebo on varying body surface areas

1 week

1 visit (in-person)

Treatment Part B

Participants receive multiple topical administrations of YR001 or placebo on high body surface area twice daily

3 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YR001

How Is the Trial Designed?

Group I: Part B, Active dose B and High body surface area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Experimental Treatment 1 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 area Placebo Group 1 Intervention

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

Group X: Part A, Placebo and Middle body surface area Placebo Group 1 Intervention

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

Group XI: Part A, Placebo and High body surface area Placebo Group 1 Intervention

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

Group XII: Part B, Placebo and High body surface area Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06309355

NCT06309355 | Topical YR001 Ointment in Adult With Mild ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/467696

Topical YR001 Ointment in Adult With Mild to Moderate ... Outcome measure. The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.

3. trial.medpath.com trial.medpath.com/clinical-trial/ded33b36c1d33437/nct06309355-randomized-placebo-controlled-trial-topical-ointment-atopic-dermatitis

Topical YR001 Ointment in Adult With Mild to Moderate Atopic ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic...

4. withpower.com withpower.com/trial/phase-1-psoriasis-1-2023-2440f

A Safety, Tolerability and Pharmacokinetics Study of ... 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. Show more. Will ...

5. synapse.patsnap.com synapse.patsnap.com/drug/abdde95df91646d98779751c852063f2

YR-001 - Drug Targets, Indications, Patents A randomized, placebo-controlled, double-blind, multi center, Phase IIa trial investigating the safety, tolerability, pharmacokinetics and efficacy of topical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05718921

Study Details | NCT05718921 | A Safety, Tolerability and ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects. ... YR001 for single topical ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-iia-trial-investigating-the-safety-tolerability-pharmacokinetics-and-efficacy-of-topical-o

Topical YR001 Ointment in Adult With Mild to Moderate Atopic ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate ...

8. yirui-pharma.com yirui-pharma.com/yirui-pharma-announces-successful-completion-of-u-s-phase-i-clinical-trial-for-yr001/

Yirui Pharma Announces Successful Completion of U.S. ... YR001 demonstrated favorable safety and tolerability in all subjects. This significant milestone marks an important advancement for Yirui Pharma ...