NCT07235384

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Detailed description

The study consists of two parts: * Part A: single ascending dose in healthy volunteers * Part B: multiple ascending doses in adult participants with moderate to severe AD

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-28
• Completion: 2027-12-28
• First posted: 2025-11-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study