This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
Clinical Trial Site
Auckland, New Zealand
Number Of Participants Experiencing Serious Adverse Events
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
Time frame: Day 1 through Day 42
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
Time frame: Day 1 through Day 42
Maximum Plasma Concentration (Cmax) Of ALXN2050
Time frame: Up to 144 hours postdose
Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050
Time frame: Up to 144 hours postdose
Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050
Time frame: Up to 144 hours postdose
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Time frame: Up to 144 hours postdose
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Time frame: Up to 144 hours postdose
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