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

Summary

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

Conditions

• Atopic Dermatitis
• Psoriasis

Interventions

DRUG

YR001 Dose A on low body surface area

Part A: Single topical dose

DRUG

YR001 Dose A on middle body surface area

Part A: Single topical dose

DRUG

YR001 Dose A on high body surface area

Part A: Single topical dose

DRUG

YR001 Dose B on low body surface area

Part A: Single topical dose

DRUG

YR001 Dose B on middle body surface area

Part A: Single topical dose

DRUG

YR001 Dose B on high body surface area

Part A: Single topical dose

DRUG

Placebo on low body surface area

Part A: Single topical dose

DRUG

Placebo on middle body surface area

Part A: Single topical dose

DRUG

Placebo on high body surface area

Part A: Single topical dose

DRUG

YR001 Dose A on high body surface area twice daily

Part B: Multiple topical dose

DRUG

YR001 Dose B on high body surface area twice daily

Part B: Multiple topical dose

DRUG

Placebo on high body surface area twice daily

Part B: Multiple topical dose

Sponsors & Collaborators

• Hangzhou Yirui Pharmaceutical Technology Co., Ltd

  lead INDUSTRY

Principal Investigators

• Stacy Smith, Dr. MD · Encinitas, California USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-08

Primary Completion

2023-08-14

Completion

2023-12-14

FDA Drug

Yes

Countries

• United States

Study Locations