The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
Research Site
Chiba, Japan
Research Site
Chūōku, Japan
Research Site
Ōta-ku, Japan
Research Site
Sendai, Japan
Research Site
Overall Summary of Adverse Events
Time frame: Stage I (up to 48 weeks)
Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
Time frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
Time frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Anti-drug Antibody (ADA)
MEDI-546 antibody detection measured by electrochemiluminescence (ECL).
Time frame: Stage I (up to Week 48)
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Shimotsuke-shi, Japan
Research Site
Shinjuku-ku, Japan