This is a randomised, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of ixekizumab (SB35 and Taltz) in healthy participants.
Healthy male or female, aged 19-55 years (inclusive) on the day of signing the informed consent form (ICF).
Have a body weight between 55.0-90.0 kg (inclusive) and a body mass index (BMI) between 20.0-29.9 kg/m2 (inclusive) at Screening and Day -1.
Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
Have vital sign results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
Have a history and/or current presence of clinically significant atopic allergy, hypersensitivity, or allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to ixekizumab or to any of the excipients.
Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, neurologic (including reversible posterior leukoencephalopathy syndrome), metabolic (including known diabetes mellitus), psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
Have a history of inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), or signs of symptoms indicative of Crohn's disease or ulcerative colitis (based on Investigator determination), or knowledge of a family history of IBD in first degree relatives.
Have a history of significant respiratory disorder (including asthma and non-infectious pneumonia).
Parallel
Ixekizumab
Drug80 mg, single-dose
AUCinf
Area under the concentration-time curve from time zero to infinity
Cmax
Maximum serum concentration
AUClast
Area under the concentration-time curve from time zero to the last quantifiable concentration
Tmax
Time to reach Cmax
Vz/F
Apparent volume of distribution during the terminal phase
λz
Terminal rate constant
t1/2
Terminal half-life
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