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

January 22, 2024 updated by: Hangzhou Yirui Pharmaceutical Technology Co., Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Written informed consent obtained from the subject
  2. Male or female subject is aged between 18 and 65 years
  3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2
  4. 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

Exclusion Criteria:

  1. 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.
  2. Pregnant or lactating women.
  3. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
  4. 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.
  5. Have active infectious disease.
  6. Subjects treated with another investigational drug, biological agent, or device
  7. Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
  8. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
  9. Active untreated mental or psychiatric disorder.
  10. Any major surgery within 6 months of screening.
  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A, Active dose A and Low body surface area
The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration
Drug: YR001 Dose A on low body surface area
Part A: Single topical dose
Experimental: Part A, Active dose A and Middle body surface area
The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration
Drug: YR001 Dose A on middle body surface area
Part A: Single topical dose
Experimental: Part A, Active dose A and High body surface area
The intervention is YR001 Dose A on high body surface area, low dose for single topical administration
Drug: YR001 Dose A on high body surface area
Part A: Single topical dose
Experimental: Part A, Active dose B and Low body surface area
The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration
Drug: YR001 Dose B on low body surface area
Part A: Single topical dose
Experimental: Part A, Active dose B and Middle body surface area
The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration
Drug: YR001 Dose B on middle body surface area
Part A: Single topical dose
Experimental: Part A, Active dose B and High body surface area
The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration
Drug: YR001 Dose B on high body surface area
Part A: Single topical dose
Placebo Comparator: Part A, Placebo and Low body surface area
The intervention is Placebo on low body surface area, Placebo for single topical administration
Drug: Placebo on low body surface area
Part A: Single topical dose
Placebo Comparator: Part A, Placebo and Middle body surface area
The intervention is Placebo on middle body surface area, Placebo for single topical administration
Drug: Placebo on middle body surface area
Part A: Single topical dose
Placebo Comparator: Part A, Placebo and High body surface area
The intervention is Placebo on high body surface area, Placebo for single topical administration
Drug: Placebo on high body surface area
Part A: Single topical dose
Experimental: Part B, Active dose A and High body surface area
The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration
Drug: YR001 Dose A on high body surface area twice daily
Part B: Multiple topical dose
Experimental: Part B, Active dose B and High body surface area
The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration
Drug: YR001 Dose B on high body surface area twice daily
Part B: Multiple topical dose
Placebo Comparator: Part B, Placebo and High body surface area
The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration
Drug: Placebo on high body surface area twice daily
Part B: Multiple topical dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
day 0 to day 8
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
day 0 to day 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: all treatment-emergent AEs
Time Frame: day 0 to day 8
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
day 0 to day 8
Part B: all treatment-emergent AEs
Time Frame: day 0 to day 22
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
day 0 to day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stacy Smith, Dr. MD, Encinitas, California USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2023

Primary Completion (Actual)

Primary Completion

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. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YR001-A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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