This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
45
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 Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
Time frame: Up to 72 hours postdose
Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
Time frame: Up to 72 hours postdose
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Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
Time frame: Up to 72 hours postdose
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Time frame: Up to 14 days postdose
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Time frame: Up to 14 days postdose