NCT05718921

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Atopic Dermatitis
• Psoriasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-08
• Primary completion: 2023-08-14
• Completion: 2023-12-14
• First posted: 2023-02-08
• Last updated: 2024-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study