Phase 1 single dose study of ALXN1101 in healthy volunteers.
This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Parexel Baltimore EPCU
Baltimore, Maryland, United States
Safety and tolerability of single dose of ALXN1101 in healthy adult subjects
Physical examination, vital signs, ECGs, laboratory evaluations, and Adverse Events.
Time frame: following the Day 30 visit for the last study subject
PK parameters of ALXN1101
PK parameters of ALXN1101 will be estimated including, but not limited to,maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (tmax), terminal elimination halflife (t½), area under the plasma concentration-time curve (AUC), total body clearance (CL), and volume of distribution (Vd).
Time frame: following the Day 5 visit for the last study subject
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