Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
Fujita Health University Hospital
Kutsukake, Aichi-ken, Japan
Number of participants with adverse events (AEs)
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.
Time frame: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169
Profile of pharmacokinetics of serum KK4277 concentration
Time frame: Part 1 : Day 1 (pre-dose, 0, 1, 6 hours after the start of administration), 2, 3, 4, 5, 6, 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, Part 2 :Enrollment, Day1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 141, 169
Time to the maximum concentration
Time frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
The maximum concentration
Time frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Area under the concentration-time curve
Time frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
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