The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
33
subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)
Investigator Site
Groningen, Netherlands
IgG levels of four different subcutaneous dose levels
Time frame: Up to 11 weeks, from study start until the end of the study
Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Number of (serious) adverse events
Time frame: Up to 11 weeks, from study start until the end of the study
Level of anti-drug antibodies
Time frame: Up to 11 weeks, from study start until the end of the study
Time required to administer the different doses
Time frame: Up to 11 weeks, from study start until the end of the study
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