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XmAb27564

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04857866Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy VolunteersPHASE1 COMPLETED 48Apr 19, 2021Nov 10, 2022Mar 1, 20231 United States
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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 — 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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