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RECRUITING
NCT07235384
PHASE1

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Sponsor: Zai Lab (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)

Official title: A Phase 1/1b Randomized, Double Blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis (AD)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-12-01

Completion Date

2027-12-28

Last Updated

2026-08-07

Healthy Volunteers

Yes

Interventions

DRUG

ZL-1503

Healthy volunteers will receive ZL-1503.

DRUG

Placebo

Healthy volunteers will receive placebo.

DRUG

ZL-1503

Participants with moderate to severe atopic dermatitis will receive ZL-1503.

DRUG

Placebo

Participants with moderate to severe atopic dermatitis will receive placebo.

Locations (12)

Veracity Clinical Research

Woolloongabba, Queensland, Australia

Skin Health Institute

Carlton, Victoria, Australia

Peking University Third Hospital

Beijing, Beijing Municipality, China

Shandong Provincial Dermatology Hospital

Jinan, Shandong, China

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Aotearoa Clinical Trials

Auckland, Auckland, New Zealand

Momentum Auckland

Takapuna, Auckland, New Zealand

Momentum Hamilton

Hamilton, Hamilton, New Zealand

Momentum Palmerston North

Palmerston North, Mananwatu, New Zealand

Momentum Hutt Valley

Upper Hutt, Wellington Region, New Zealand

Momentum Kapiti

Waikanae, Wellington Region, New Zealand