This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled, ascending dose study to investigate the safety, tolerability, and pharmacokinetics of XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States
Number of adverse events including type and severity
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 43
Time frame: Date of randomization up to Day 43
Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 36
Time frame: Date of randomization up to Day 36
Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195
Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial dosing up to Day 43
Time frame: Time of dosing up to Day 43
Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after a priming IV dose followed by an escalating second IV dose of XmAb7195
Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36
Time frame: Time of dosing up to Day 36
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