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A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

This is a phase 1, single dose, randomized, open-label, parallel-group study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of ZL-1503 and to explore its PD biomarkers following a single subcutaneous (SC) or intravenous (IV) administration in healthy volunteers.

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.

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 a single intravenous dose of ZL-1503.

  • ZL-1503

    Drug

    Healthy volunteers will receive a single subcutaneous administration at Dose 1.

  • ZL-1503

    Drug

    Healthy volunteers will receive a single subcutaneous administration at Dose 2.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: ZL-1503 (Intravenous Administration)Experimental treatment 1 intervention
Group B: ZL-1503 (Subcutaneous Dose 1)Experimental treatment 1 intervention
Group C: ZL-1503 (Subcutaneous Dose2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum plasma concentration (Cmax)

Time frame
From Predose to Day 337
2

Time to maximum concentration (Tmax)

Time frame
From Predose to Day 337
3

Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)

Time frame
From Predose to Day 337
4

Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

Time frame
From Predose to Day 337

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

This trial is not recruiting at the moment. You can still explore other options: