Healthy VolunteersPhase 1NCT07658482
A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers
A Phase 1 study testing ZL-1503 in people with Healthy Volunteers, run by Zai Lab (Shanghai) Co., Ltd. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ZL-1503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNew Zealand
- Study dates
- 3 Sep 2026to 10 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.
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.
- Conditions
- Healthy Volunteers
- Being tested
- ZL-1503
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1503Drug
Healthy volunteers will receive a single intravenous dose of ZL-1503.
ZL-1503Drug
Healthy volunteers will receive a single subcutaneous administration at Dose 1.
ZL-1503Drug
Healthy volunteers will receive a single subcutaneous administration at Dose 2.
| Study group | Role | What they receive |
|---|---|---|
| ZL-1503 (Intravenous Administration) | Experimental | Not described Receives: Drug: ZL-1503 |
| ZL-1503 (Subcutaneous Dose 1) | Experimental | Not described Receives: Drug: ZL-1503 |
| ZL-1503 (Subcutaneous Dose2) | Experimental | Not described Receives: Drug: ZL-1503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: From Predose to Day 337
Time to maximum concentration (Tmax)
Measured: From Predose to Day 337
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Measured: From Predose to Day 337
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Measured: From Predose to Day 337
Apparent terminal elimination half-life (t1/2)
Measured: From Predose to Day 337
Apparent total body clearance (CL/F)
Measured: From Predose to Day 337
Apparent volume of distribution (Vz/F)
Measured: From Predose to Day 337
Steady State Volume of distribution (Vss IV)
Measured: From Predose to Day 337
Total Body Clearance (CL IV)
Measured: From Predose to Day 337
Absolute bioavailability (F)
Measured: From Predose to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start3 Sep 2026 (estimated)
- Primary completion6 Feb 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658482
- Sponsor's protocol ID
- ZL-1503-002
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT07658482
- Acronym / sponsor ID
- ZL-1503-002
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZL-1503 (Intravenous Administration) | Experimental | Drug: ZL-1503 |
| ZL-1503 (Subcutaneous Dose 1) | Experimental | Drug: ZL-1503 |
| ZL-1503 (Subcutaneous Dose2) | Experimental | Drug: ZL-1503 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1503Healthy volunteers will receive a single intravenous dose of ZL-1503. | Drug | ZL-1503 (Intravenous Administration) |
| ZL-1503Healthy volunteers will receive a single subcutaneous administration at Dose 1. | Drug | ZL-1503 (Subcutaneous Dose 1) |
| ZL-1503Healthy volunteers will receive a single subcutaneous administration at Dose 2. | Drug | ZL-1503 (Subcutaneous Dose2) |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: From Predose to Day 337
Time to maximum concentration (Tmax)
Time frame: From Predose to Day 337
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Time frame: From Predose to Day 337
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: From Predose to Day 337
Apparent terminal elimination half-life (t1/2)
Time frame: From Predose to Day 337
Apparent total body clearance (CL/F)
Time frame: From Predose to Day 337
Apparent volume of distribution (Vz/F)
Time frame: From Predose to Day 337
Steady State Volume of distribution (Vss IV)
Time frame: From Predose to Day 337
Total Body Clearance (CL IV)
Time frame: From Predose to Day 337
Absolute bioavailability (F)
Time frame: From Predose to Day 337
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZL-1503 in people with Healthy Volunteers, run by Zai Lab (Shanghai) Co., Ltd. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZaiLab Medical Director (+86 021-61632588, ZL-1503-002_StudyTeam@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: From Predose to Day 337). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.