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

NCT05718921 | Completed Phase 1 FDA Drug

• 1 other identifier: YR001-A01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.

Conditions

Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Part A: Safety and Maximum Tolerate Dose (MTD)

  Incidence of treatment related AEs (TRAEs) and local skin tolerance

  day 0 to day 8

• Part B: Safety and Maximum Tolerate Dose (MTD)

  Incidence of treatment related AEs (TRAEs) and local skin tolerance

  day 0 to day 22

Secondary Outcomes (2)

• Part A: all treatment-emergent AEs

  day 0 to day 8

• Part B: all treatment-emergent AEs

  day 0 to day 22

Study Arms (12)

Part A, Active dose A and Low body surface area

EXPERIMENTAL

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, Active dose A and Middle body surface area

EXPERIMENTAL

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, Active dose A and High body surface area

EXPERIMENTAL

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, Active dose B and Low body surface area

EXPERIMENTAL

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, Active dose B and Middle body surface area

EXPERIMENTAL

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, Active dose B and High body surface area

EXPERIMENTAL

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, Placebo and Low body surface area

PLACEBO COMPARATOR

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

Drug: Placebo on low body surface area

Part A, Placebo and Middle body surface area

PLACEBO COMPARATOR

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

Drug: Placebo on middle body surface area

Part A, Placebo and High body surface area

PLACEBO COMPARATOR

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

Drug: Placebo on high body surface area

Part B, Active dose A and High body surface area

EXPERIMENTAL

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, Active dose B and High body surface area

EXPERIMENTAL

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, Placebo and High body surface area

PLACEBO COMPARATOR

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

Interventions

YR001 Dose A on low body surface area DRUG

Part A: Single topical dose

Part A, Active dose A and Low body surface area

YR001 Dose A on middle body surface area DRUG

Part A: Single topical dose

Part A, Active dose A and Middle body surface area

YR001 Dose A on high body surface area DRUG

Part A: Single topical dose

Part A, Active dose A and High body surface area

YR001 Dose B on low body surface area DRUG

Part A: Single topical dose

Part A, Active dose B and Low body surface area

YR001 Dose B on middle body surface area DRUG

Part A: Single topical dose

Part A, Active dose B and Middle body surface area

YR001 Dose B on high body surface area DRUG

Part A: Single topical dose

Part A, Active dose B and High body surface area

Placebo on low body surface area DRUG

Part A: Single topical dose

Part A, Placebo and Low body surface area

Placebo on middle body surface area DRUG

Part A: Single topical dose

Part A, Placebo and Middle body surface area

Placebo on high body surface area DRUG

Part A: Single topical dose

Part A, Placebo and High body surface area

YR001 Dose A on high body surface area twice daily DRUG

Part B: Multiple topical dose

Part B, Active dose A and High body surface area

YR001 Dose B on high body surface area twice daily DRUG

Part B: Multiple topical dose

Part B, Active dose B and High body surface area

Placebo on high body surface area twice daily DRUG

Part B: Multiple topical dose

Part B, Placebo and High body surface area

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
• 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.
• Have active infectious disease.
• Subjects treated with another investigational drug, biological agent, or device
• Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
• Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
• Active untreated mental or psychiatric disorder.
• Any major surgery within 6 months of screening.
• 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.
• \. Drug or alcohol abuse history.

Sponsors & Collaborators

• Hangzhou Yirui Pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Study Officials

• Stacy Smith, Dr. MD

  Encinitas, California USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes two sequential parts of single dose and multiple dose with placebo control

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: April 8, 2023
• Primary Completion: August 14, 2023
• Study Completion: December 14, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)