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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

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

Qualifiers

Healthy male and female volunteers, 18-65 years of age

Body mass index (BMI) between ≥ 18.5 and < 32.5 kg/m2

Negative pregnancy tests for women of childbearing potential.

18-65 years of age;

Disqualifiers

Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.

History of major metabolic, liver, kidney, hematologic or other significant disorders.

Abnormal Electrocardiogram (ECG) findings

Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.

Trial design

Treatments tested in this trial

  • ZL-1503
  • Placebo
  • ZL-1503
  • Placebo

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators