The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
58
sterile solution for infusion
sterile solution for infusion
sterile powder for injection
CenExel CNS
Long Beach, California, United States
Frontage Clinical Research Inc
Secaucus, New Jersey, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the day of study drug administration (Day 1) up to end of study (Day 113)
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Maximum Observed Plasma Concentration (Cmax) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Time to Reach Cmax (Tmax) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Elimination Half-life (t1/2) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Total Serum Clearance (CL) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Mean Residence Time (MRT) of Lu AG22515
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)