This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Experimental
Placebo
Spyre Site 2
Cypress, California, United States
Spyre Site 1
Montreal, Quebec, Canada
Treatment emergent adverse events
Incidence, severity, and causal relationship of TEAEs
Time frame: Up to 40 weeks
Cmax
Maximum concentration after single dose
Time frame: Up to 40 weeks
t1/2
Half life after single dose
Time frame: Up to 40 weeks
Tmax
Time to reach maximum concentration after single dose
Time frame: Up to 40 weeks
ADA
Incidence of anti-drug antibody after single dose
Time frame: Up to 40 weeks
AUC
Area under the curve after single dose
Time frame: Up to 40 weeks
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