This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
Duration per participant is up to 11 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
injection solution subcutaneous
Prism Research-Site Number:840001
Saint Paul, Minnesota, United States
Maximum serum concentration of functional dupilumab (Cmax)
Time frame: Pre-dose on Day 1 up to Day 57
Time to reach Cmax (Tmax)
Time frame: Pre-dose on Day 1 up to Day 57
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
Time frame: Pre-dose on Day 1 up to Day 57
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 up to Day 57
Incidence of anti-dupilumab antibodies (ADA)
Time frame: Day 1 up to Day 57
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