A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult 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

54 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What safety data exists for the treatment YR001?

The treatment YR001, also known as a neuropeptide Y2 receptor agonist, has been studied for its effects on body weight and has shown to cause severe vomiting in dogs at certain doses. Modified versions of the treatment have been developed to reduce this side effect by altering how the drug is absorbed in the body. ^{1 2 3 4 5}

What makes the drug YR001 unique compared to other treatments?

YR001 may involve components like YB-1, which is known for its versatile roles in gene expression and cell processes, potentially offering a novel mechanism of action compared to existing treatments. This could make YR001 distinct in how it targets and regulates cellular functions, especially in conditions where YB-1's involvement is significant. ^{6 7 8 9 10}

Research Team

Stacy Smith, Dr. MD

Principal Investigator

Encinitas, California USA

Eligibility Criteria

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

Male or female subject is aged between 18 and 65 years

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

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

Treatment Details

Interventions

• YR001

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Unusually persistent Gαi-signaling of the neuropeptide Y2 receptor depletes cellular Gi/o pools and leads to a Gi-refractory state. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The pharmacological properties of Y-23684, a benzodiazepine receptor partial agonist. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of an extended-release peptide YY analogue for obesity: A randomized, placebo-controlled, phase 1 trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Antiobesity and emetic effects of a short-length peptide YY analog and its PEGylated and alkylated derivatives. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Delayed stress-induced differences in locomotor and depression-related behaviour in female neuropeptide-Y Y1 receptor knockout mice. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Yin Yang 1 extends the Myc-related transcription factors network in embryonic stem cells. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Why YRNAs? About Versatile RNAs and Their Functions. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

YB-1 as an Oncoprotein: Functions, Regulation, Post-Translational Modifications, and Targeted Therapy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

YB-1 protein: functions and regulation. [2014]

10. England pubmed.ncbi.nlm.nih.gov

YB-1 promotes microtubule assembly in vitro through interaction with tubulin and microtubules. [2021]