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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

ConditionAtopic Dermatitis (AD)
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ZL-1503

    Drug

    Healthy volunteers will receive ZL-1503.

  • Placebo

    Drug

    Healthy volunteers will receive placebo.

  • ZL-1503

    Drug

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

  • Placebo

    Drug

    Participants with moderate to severe atopic dermatitis will receive placebo.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: ZL-1503: Participants will receive single ascending doses of ZL-1503Experimental treatment 2 interventions
Group B: ZL-1503: Participants will receive multiple ascending doses of ZL-1503Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 48 weeks after last intervention
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 48 weeks after last intervention
3

Number of participants with clinical laboratory abnormalities

Time frame
Up to 48 weeks after last intervention
4

Number of participants with vital sign abnormalities

Time frame
Up to 48 weeks after last intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zai Lab (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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