The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Number and percentage of subjects with Treatment Emergent Adverse Events
To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Cmax)
To assess the maximum plasma concentration (Cmax)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (Tmax)
To assess the time of maximum concentration (Tmax)
Time frame: Up to 10 weeks
Pharmacokinetics profile of CUG252 (t1/2)
To assess the half-life (t1/2)
Time frame: Up to 10 weeks
Immunogenicity of CUG252
To measure the serum concentration of antibodies against CUG252
Time frame: Up to 10 weeks
Change in the number and percentages of immune cells
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.
Time frame: Up to 10 weeks
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