This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
LEO 138559 is an antibody given by injection just under the skin.
LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559.
LEO Investigational Site
Los Angeles, California, United States
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
Cmax: maximum serum LEO 138559 concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
tmax: time of maximum serum LEO 138559 concentration
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
t½: terminal elimination half-life
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
CL/F: apparent total body clearance
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
Vz/F: apparent volume of distribution
Pharmacokinetic endpoint to be determined from serum concentrations
Time frame: From Day 1 to Day 85
Number of treatment emergent adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Day 1 to Day 85
Presence of binding anti-drug antibodies
Time frame: Day 1(pre-dose), Day 29, Day 57, and Day 85