The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Lu AF82422 solution for intravenous infusion
Zhongshan Hospital Fudan University
Shanghai, China
Number of participants with treatment-emergent adverse events (safety and tolerability)
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Time frame: From Day 1 to Day 140
Number of participants with anti-drug antibodies
Time frame: From Day 1 to Day 140
Cmax: maximum observed plasma concentration of Lu AF82422
Time frame: From Day 1 to Day 140
Tmax: time to maximum observed concentration of Lu AF82422
Time frame: From Day 1 to Day 140
AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422
Time frame: From Day 1 to Day 140
AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422
Time frame: From Day 1 to Day 140
AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422
Time frame: From Day 1 to Day 140
AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422
Time frame: From Day 1 to Day 140
t1/2: apparent terminal elimination half-life of Lu AF82422
Time frame: From Day 1 to Day 140
MRT: mean residence time of Lu AF82422
Time frame: From Day 1 to Day 140
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CL: systemic clearance of Lu AF82422
Time frame: From Day 1 to Day 140
t1/2eff: effective elimination half-life of Lu AF82422
Time frame: From Day 1 to Day 140
Vz: apparent volume of distribution of Lu AF82422
Time frame: From Day 1 to Day 140
Vss: steady-state volume of distribution of Lu AF82422
Time frame: From Day 1 to Day 140