A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis

Summary

This is a phase Ib/II, randomized, double-blind, placebo-controlled, parallel, multicenter study of a certain phase to evaluate the efficacy, safety, and pharmacokinetic characteristics of QY201 tablet in subjects in moderate to severe atopic dermatitis

Conditions

• Atopic Dermatitis

Interventions

DRUG

2mg QY201 tablets or 2mg QY201 placebo,BID

2mg QY201 tablets or 2mg QY201 placebo,BID

DRUG

5mg QY201 tablets or 5mg QY201 placebo,BID

5mg QY201 tablets or 5mg QY201 placebo,BID

DRUG

10mg QY201 tablets or 10mg QY201 placebo,QD

10mg QY201 tablets or 10mg QY201 placebo,QD

DRUG

10mg QY201 tablets or 10mg QY201 placebo,BID

10mg QY201 tablets or 10mg QY201 placebo,BID

DRUG

15mg QY201 tablets or 15mg QY201 placebo,BID

15mg QY201 tablets or 15mg QY201 placebo,BID

DRUG

20mg QY201 tablets or 20mg QY201 placebo,BID

20mg QY201 tablets or 20mg QY201 placebo,BID

DRUG

5mg QY201 tablets，BID

5mg QY201 tablets，BID

DRUG

10mg QY201 tablets，BID

10mg QY201 tablets，BID

DRUG

20mg QY201 tablets，BID

20mg QY201 tablets，BID

DRUG

QY201 placebo，BID

QY201placebo，BID

Sponsors & Collaborators

• E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.

  lead INDUSTRY

Principal Investigators

• LiMing Wu, Ph.D, M.D · Affiliated Hangzhou First People's Hospital of Zhejiang University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-31

Primary Completion

2025-12-31

Completion

2025-12-31