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Cendakimab

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Aug 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05638282A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy ParticipantsPHASE1 COMPLETED 25 — — Feb 15, 2023Jun 27, 2023Aug 1, 20231 China
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Study Endpoints
Primary Endpoints
Maximum Observed Serum Concentration (Cmax)
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Predose and at multiple timepoints (up to 105 days) after dosing
Secondary Endpoints
Number of Participants with Treatment-emergent Adverse Events
Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Screening (Days -28 to -1) through Day 105
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CendakimabEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CendakimabDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be Chinese (both biological parents are ethnically Chinese). * Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2. * Body weight ≥ 50.0 kg. Exclusion Criteria: * History of clinically...

Countries:China
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