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The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZB001 for injection | Experimental | Treated different dose cohorts with single intravenous injection of ZB001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZB001 for injection | Drug | Dose Cohort1 (3mg/kg) ZB001 of single IV injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 | during the study, up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ZB001 concentrations in the blood over time | PK parameters in the blood over time. | Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks |
| Serum ZB001 antidrug antibody (ADA) titers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | 200030 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| ZB001 for injection |
| Drug |
Dose Cohort2 (10mg/kg) ZB001 of single IV injection |
|
| ZB001 for injection | Drug | Dose Cohort3 (20mg/kg) ZB001 of single IV injection |
|
antidrug antibody (ADA) titers of ZB001
| Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks |