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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or F | Experimental |
| |
| Single Ascending Dose - Placebo Subcutaneous injection of placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb27564 | Drug | Single ascending dose of XmAb27564 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0 | Up to Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Drug Concentration - Time Curve from Zero to the End of Observation | 45 Days | |
| PK: Maximum Observed Drug Concentration (Cmax) of XmAb27564 after a single dose | 45 Days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Zitnik, MD | Executive Medical Director, Clinical Development, Xencor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | United States |
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| Placebo | Drug | Single dose of placebo |
|
| PK: Measurement of Cmax |
| 45 Days |
| PK: Time to Maximum Plasma Concentration (Tmax) of XmAb27564 after a single dose | 45 Days |
| PK: Measurement of Tmax | 45 Days |
| PK: Time to Decrease in Concentration by Half (T1/2) of XmAb27564 after a single dose, due to elimination | 45 Days |
| PK: Measurement of T1/2 | 45 Days |
| PD: Measurement of Change in Number of Regulatory T Cells | 45 Days |
| PD: Measurement of Change in Number of Subsets of Conventional T Cells in Blood | 45 Days |
| PD: Measurement of Change in Number of Natural Killer Cells (NK Cells) in Blood | 45 Days |
| PD: Measurement of Cytokines in Blood | 45 Days |