A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volun… (NCT07658482) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers
New Zealand36 participantsStarted 2026-09-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* History of drug abuse or addiction within 6 months prior to screening
* Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.
* Donated \>500mL blood within 2 months of dosing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum plasma concentration (Cmax)
Timeframe: From Predose to Day 337
2
Time to maximum concentration (Tmax)
Timeframe: From Predose to Day 337
3
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Timeframe: From Predose to Day 337
4
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)