This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Veritus Research
Bayswater, Victoria, Australia
RECRUITINGNumber of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
Time frame: 2 months
To assess the maximum serum concentration (CMAX)
Time frame: 2 months
To assess time to reach maximum serum concentration (tMAX)
Time frame: 2 months
To assess elimination half-life (t1/2)
Time frame: 2 months
To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)
Time frame: 2 months
To assess clearance (CL)
Time frame: 2 months
To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)
Time frame: 2 months
To assess bioavailability after SC administration (F%)
Time frame: 2 months
To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints
Time frame: 2 months
Incidence and characterization of anti-drug antibody (ADA)
Time frame: 2 months
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