A Phase 1 interventional study of XmAb27564 and Placebo in Safety in Healthy Volunteers, sponsored by Xencor, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Xencor, Inc. · Phase 1, Interventional, and Treatment
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.
Xencor, Inc. is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 2 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: XmAb27564
Drug: Placebo
Single ascending dose of XmAb27564
Single dose of placebo
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
PD: Measurement of Cytokines in Blood
Time frame: 45 Days
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Xencor, Inc.