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ABP 501-HCF

Phase 1

Adalimumab | Small molecule | Other |Amgen Inc.|Last Updated: Jun 18, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment372
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05909852A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult ParticipantsPHASE1 COMPLETED 372 — — Jul 23, 2021Nov 24, 2021Jun 18, 20233 United States
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Study Endpoints
Primary Endpoints
AUCinf of ABP 501-HCF and ABP 501-LCF
Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Cmax of ABP 501-HCF and ABP 501-LCF
Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Secondary Endpoints
AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF
Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Time at which Cmax is Observed (Tmax) of ABP 501-HCF and ABP 501-LCF
Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Terminal Elimination Half-life (t1/2) of ABP 501-HCF and ABP 501-LCF
Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment A: ABP 501-HCFEXPERIMENTALParticipants will be administered a single SC dose of ABP 501-HCF on Day 1.
Treatment B: ABP 501-LCFEXPERIMENTALParticipants will be administered a single SC dose of ABP 501-LCF on Day 1.
Interventions
NameTypeDescription
ABP 501-HCFDRUGParticipants will receive a single-dose SC injection of ABP 501-HCF.
ABP 501-LCFDRUGParticipants will receive a single-dose SC injection of ABP 501-LCF
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Participants must sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form (ICF) before any study-specific procedures are performed. * Healthy adult male or female participants between 18 and 55 years of age, inclusive, at the ti...

Countries:United States
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