Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study. Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
IV / Single administration
SC / Single administration
IV / Multiple administration
Osaka Pharmacology Clinical research Hospital
Osaka, Japan
Number of participants with adverse events
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.
Time frame: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225
Profile of pharmacokinetics of serum KHK4323 concentration in Part 1
Anti-KHK4323 antibodies
Time frame: Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169
Profile of pharmacokinetics of serum KHK4323 concentration in Part 2
Anti-KHK4323 antibodies
Time frame: Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225
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IV / Single administration
IV / Multiple administration
SC / Single administration