This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
Clinical Trial Site
Tempe, Arizona, United States
Number Of Participants With Treatment-emergent Adverse Events
see Time Frame - defined
Time frame: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Cmax For Multiple-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Tmax For Multiple-dose ALXN2050
see Time Frame - defined
Time frame: Up to 72 hours postdose
Alternative Pathway Activity As Measured By Wieslab Assay
see Time Frame - defined
Time frame: Up to 72 hours postdose
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Complement Factor B Fraction b Levels
see Time Frame - defined
Time frame: Up to 72 hours postdose