The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Kanazawa, Japan
Research Site
Kawagoe-shi, Japan
Number of Participants With Each Category of Adverse Events in Stage I
Time frame: Stage I (up to 1 year)
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Time frame: Stage II (1 year to 3.5 years after first dose)
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I (0 upto 28 days)
AUC0-14 of MEDI-545 After First Dose in Stage I
Summary of area under the concentration-time curve from zero to Day 14.
Time frame: After first dose in Stage I
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I
Change From Baseline in 21-gene Signature Fold Change in Stage I
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Time frame: Stage I
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time frame: Stage I
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Research Site
Kitakyushu-shi, Japan
Research Site
Sapporo, Japan
Research Site
Shinjuku-ku, Japan