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
Condition(s) studied
Investigational drug(s) / intervention(s)
ZL-1503: Healthy volunteers will receive ZL-1503.
Placebo: Healthy volunteers will receive placebo.
ZL-1503: Participants with moderate to severe atopic dermatitis will receive ZL-1503.
Placebo: Participants with moderate to severe atopic dermatitis will receive placebo.
Study 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)
Eligibility
Primary outcome measure(s)
- Number of participants with adverse events (AEs) — Up to 48 weeks after last intervention
- Number of participants with serious adverse events (SAEs) — Up to 48 weeks after last intervention
- Number of participants with clinical laboratory abnormalities — Up to 48 weeks after last intervention
- Number of participants with vital sign abnormalities — Up to 48 weeks after last intervention
- Number of participants with electrocardiogram (ECG) abnormalities — Up to 48 weeks after last intervention
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Veracity Clinical Research | Woolloongabba | Queensland | Recruiting |
| Skin Health Institute | Carlton | Victoria | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
| Shandong Provincial Dermatology Hospital | Jinan | Shandong | Recruiting |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | Recruiting |
| Aotearoa Clinical Trials | Auckland | Auckland | Recruiting |
| Momentum Auckland | Takapuna | Auckland | Recruiting |
| Momentum Hamilton | Hamilton | Hamilton | Recruiting |
| Momentum Palmerston North | Palmerston North | Mananwatu | Recruiting |
| Momentum Hutt Valley | Upper Hutt | Wellington Region | Recruiting |
| Momentum Kapiti | Waikanae | Wellington Region | Recruiting |
More Zai Lab (Shanghai) Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07235384 on ClinicalTrials.gov ↗ ← All trials in China