This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of methotrexate weekly throughout participation in the study. This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2 subjects will receive placebo. Subjects participating in one dose group will be ineligible to participate in another dose group in the study.
Multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
8
subcutaneous injection
Placebo for ABBV-257
Site Reference ID/Investigator# 139394
Berlin, Germany
Proportion of subjects with adverse events
This will be collected through out the study
Time frame: Up to day 193
Change in Vital signs
Vital signs including blood pressure and heart rate will be assessed
Time frame: From day 1 to day 193
Change in Physical examination
Changes in any physical exam assessed by the physician will be assessed.
Time frame: From day 1 to day 193
Changes in Electrocardiogram (ECG)
ECG measurements will be assessed
Time frame: From day 1 to day 193
Maximum observed serum concentration (Cmax)
This will be assessed using non-compartmental methods.
Time frame: Up to day 50
Time to maximum observed serum concentration (Tmax)
This will be assessed using non-compartmental methods.
Time frame: Up to day 50
Immunogenicity by measurement of Anti-drug antibody
Immunogenicity will be measured to see if the body has produced an immune response to ABBV-257
Time frame: Up to day 193
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