NCT05843422

A First-in-Human Study of QY211 Gel in Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients With Mild to Moderate Atopic Dermatitis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients with Mild to Moderate Atopic Dermatitis

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	0.1% QY211 Gel or placebo	QY211 Gel or placebo topical applied to skin
DRUG	0.3% QY211 Gel or placebo	QY211 Gel or placebo topical applied to skin
DRUG	0.8% QY211 Gel or placebo	QY211 Gel or placebo topical applied to skin
DRUG	1.5% QY211 Gel or placebo	QY211 Gel or placebo topical applied to skin

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: China