This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending-dose study of subcutaneously administered XmAb27564 or placebo in healthy male and female subjects.
This study will determine the safety and tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of XmAb27564 in normal healthy volunteers. XmAb27564 is an engineered IL-2 mutein being developed for autoimmune diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0
Time frame: Up to Day 45
PK: Area Under the Drug Concentration - Time Curve from Zero to the End of Observation
Time frame: 45 Days
PK: Maximum Observed Drug Concentration (Cmax) of XmAb27564 after a single dose
Time frame: 45 Days
PK: Measurement of Cmax
Time frame: 45 Days
PK: Time to Maximum Plasma Concentration (Tmax) of XmAb27564 after a single dose
Time frame: 45 Days
PK: Measurement of Tmax
Time frame: 45 Days
PK: Time to Decrease in Concentration by Half (T1/2) of XmAb27564 after a single dose, due to elimination
Time frame: 45 Days
PK: Measurement of T1/2
Time frame: 45 Days
PD: Measurement of Change in Number of Regulatory T Cells
Time frame: 45 Days
PD: Measurement of Change in Number of Subsets of Conventional T Cells in Blood
Time frame: 45 Days
PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood
Time frame: 45 Days
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PD: Measurement of Cytokines in Blood
Time frame: 45 Days