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XmAb27564

Phase 1

Safety in Healthy Volunteers | Small molecule | Other |Xencor, Inc.|Last Updated: Mar 1, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

XmAb27564 · 1 trial · 1 indication

Phase 1 1
NCT04857866Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy VolunteersSafety in Healthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0
Up to Day 45

Secondary Endpoints

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
PK: Measurement of Cmax
45 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or FEXPERIMENTAL -
Single Ascending Dose - Placebo Subcutaneous injection of placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
XmAb27564DRUGSingle ascending dose of XmAb27564
PlaceboDRUGSingle dose of placebo
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Total body weight 50.0 to 100.0 kg and body mass index (BMI) 19.0 to 35.0 kg/m2 * In good general health with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease. * A ...

Countries:United States
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Frequently asked questions about XmAb27564

What is XmAb27564 used for?

XmAb27564 is an investigational small molecule being studied for safety in healthy volunteers. It is in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics after a single subcutaneous injection. The drug is not approved and remains in clinical development.

Who makes XmAb27564?

XmAb27564 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker XNCR. The company conducted a Phase 1 clinical trial of the drug in healthy volunteers in the United States.

What phase is XmAb27564 in?

XmAb27564 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not FDA approved. It remains investigational and is being studied for safety in healthy volunteers.

What clinical trials is XmAb27564 in?

XmAb27564 has one completed clinical trial, NCT04857866, titled 'Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers.' This Phase 1, randomized, double-blind, placebo-controlled study enrolled 48 participants in the United States.

Is XmAb27564 FDA approved?

XmAb27564 is not FDA approved. It is an investigational drug in Phase 1 clinical development. A single Phase 1 trial in healthy volunteers has been completed, but the drug has not received regulatory approval.