This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
49
Altasciences Clinical LA, Inc.
Cypress, California, United States
Incidence, severity, causal relationship of treatment emergent adverse events
Time frame: Up to 14 Weeks
F% in Caucasian subjects
Mean SC versus IV AUC(inf) values
Time frame: Up to 10 Weeks
Cmax in Japanese subjects
Maximum concentration after single dose
Time frame: Up to 14 Weeks
Tmax in Japanese subjects
Time to reach maximum concentration after single dose
Time frame: Up to 14 Weeks
Cmax in Caucasian subjects
Maximum concentration after single dose
Time frame: Up to 10 Weeks
Tmax in Caucasian subjects
Time to reach maximum concentration after single dose
Time frame: Up to 10 Weeks
Immunogenicity rate
Time frame: Up to 14 Weeks
Change in sTL1A levels
Time frame: Up to 14 Weeks
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Placebo
Drug