Recent Updates
Recently added Catalysts

ABP 501-HCF

Phase 1

Adalimumab | Small molecule | Immunology |Amgen Inc.|Last Updated: Jun 25, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment372

FDA Designations

No designations recorded

Clinical trial landscape

ABP 501-HCF · 1 trial · 1 indication

Phase 1 1
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 ParticipantsAdalimumab
COMPLETED372 Analytics
PHASE1COMPLETED
A 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 Participants
AdalimumabUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMJul 26, 2026NCT05909852TRIAL_REMOVED: changed
MEDIUMJul 26, 2026NCT05909852TRIAL_REMOVED: changed
MEDIUMJul 26, 2026NCT05909852TRIAL_REMOVED: changed

Frequently asked questions about ABP 501-HCF

What is ABP 501-HCF used for?

ABP 501-HCF is an investigational small molecule being developed for adalimumab, which is an immunology condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes ABP 501-HCF?

ABP 501-HCF is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN.

What phase is ABP 501-HCF in?

ABP 501-HCF is in Phase 1 clinical development. It is an investigational drug and has not been approved for commercial use.

What clinical trials is ABP 501-HCF in?

ABP 501-HCF has one completed Phase 1 trial, NCT05909852, which compared its pharmacokinetics with another formulation in healthy adult participants. The trial enrolled 372 participants in the United States.

Is ABP 501-HCF the same as ABP 501-LCF?

ABP 501-HCF and ABP 501-LCF are different formulations of the same drug, ABP 501. The HCF version is 40 mg/0.4 mL, while the LCF version is 40 mg/0.8 mL, and they were compared in a clinical trial.