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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZL-1503 (Intravenous Administration) | Experimental |
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| ZL-1503 (Subcutaneous Dose 1) | Experimental |
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| ZL-1503 (Subcutaneous Dose2) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-1503 | Drug | Healthy volunteers will receive a single intravenous dose of ZL-1503. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | From Predose to Day 337 | |
| Time to maximum concentration (Tmax) | From Predose to Day 337 | |
| Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) | From Predose to Day 337 | |
| Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | From Predose to Day 337 | |
| Apparent terminal elimination half-life (t1/2) | From Predose to Day 337 | |
| Apparent total body clearance (CL/F) | From Predose to Day 337 | |
| Apparent volume of distribution (Vz/F) | From Predose to Day 337 | |
| Steady State Volume of distribution (Vss IV) | From Predose to Day 337 | |
| Total Body Clearance (CL IV) | From Predose to Day 337 | |
| Absolute bioavailability (F) | From Predose to Day 337 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZaiLab Medical Director | Contact | +86 021-61632588 | ZL-1503-002_StudyTeam@zailaboratory.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZaiLab Site 18001 | Auckland | Auckland | New Zealand |
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| ZL-1503 | Drug | Healthy volunteers will receive a single subcutaneous administration at Dose 1. |
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| ZL-1503 | Drug | Healthy volunteers will receive a single subcutaneous administration at Dose 2. |
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