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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Dose Cohort1 (3mg/kg) ZB001 of single IV injection
Dose Cohort2 (10mg/kg) ZB001 of single IV injection
Dose Cohort3 (20mg/kg) ZB001 of single IV injection
Shanghai Mental Health Center
Shanghai, China
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: during the study, up to 4 weeks
ZB001 concentrations in the blood over time
PK parameters in the blood over time.
Time frame: 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
antidrug antibody (ADA) titers of ZB001
Time frame: Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
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