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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
Conditions: Atopic Dermatitis (AD)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 84
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Location: Veracity Clinical Research Woolloongabba Queensland
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 Criteria
Inclusion Criteria:
* Part A:
1. Healthy male and female volunteers, 18-65 years of age
2. Body mass index (BMI) between ≥ 18.5 and \< 32.5 kg/m2
3. Negative pregnancy tests for women of childbearing potential.
* Part B:
1. 18-65 years of age;
2. BMI between ≥18.5 and \500mL blood within 2 months of dosing.
* For Part B only:
1. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.
2. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
3. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Source: ClinicalTrials.gov (NCT07235384). StuddyBuddy aggregates publicly available trial information.