The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
CUG252 is a potential best-in-class engineered IL-2 compound, designed to have improved Treg selectivity while reducing undesired IL-2 activity. This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunologic effects of CUG252 following subcutaneous administration of multiple ascending doses in participants with mild-to-moderate SLE. The effects of SLE disease activity and biomarkers will also be evaluated.. The SLE participants will receive randomized multiple subcutaneous doses of CUG252 or placebo. After receiving the last dose of CUG252 or placebo, participants will be followed to study day 64 post first dose administration to evaluate safety, PK, PD and preliminary efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Site 1001
Anniston, Alabama, United States
Site 1011
La Jolla, California, United States
Site 1002
Clearwater, Florida, United States
Site 1009
Tampa, Florida, United States
Number and percentage of subjects with Treatment Emergent Adverse Events
To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.
Time frame: Up to 64 Days
Pharmacokinetics profile of CUG252 (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Cmax)
To assess the maximum plasma concentration (Cmax)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Tmax)
To assess the time of maximum concentration (Tmax)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (t1/2)
To assess the half-life (t1/2)
Time frame: Day 1 pre dose through Day 64
Immunogenicity of CUG252
To measure the serum concentration of antibodies against CUG252
Time frame: Day 1 pre dose through Day 64
Change in the number and percentages of immune cells
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.
Time frame: Day 1 pre dose through Day 64
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Site 1007
Lawrenceville, Georgia, United States
Site 1010
Columbus, Ohio, United States
Site 1005
Middleburg Heights, Ohio, United States
Site 1003
Duncansville, Pennsylvania, United States
Site 1006
Dallas, Texas, United States
Site 1004
Mesquite, Texas, United States
...and 1 more locations