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AMG 592

Phase 1

Chronic Graft-versus-Host Disease (cGVHD) | Small molecule | Immunology |Amgen Inc.|Last Updated: Jun 2, 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 Trials2
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05885451A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese ParticipantsPHASE1 COMPLETED 18 — — Jan 29, 2019Apr 11, 2019Jun 2, 20231 Australia
NCT05873907A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy ParticipantsPHASE1 COMPLETED 64 — — Oct 19, 2015Jul 28, 2017May 24, 20231 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Serum Concentration (Cmax) of AMG 592
Up to Day 43
Time of Maximum Observed Concentration (tmax) of AMG 592
Up to Day 43
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Up to Day 43
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
Up to Day 43
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 up to Day 57

Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.

Number of Participants with Anti-AMG 592 Antibodies
Day 1 up to Day 57
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
One week after AMG 592 administration (up to 7 days)
Secondary Endpoints
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Day 1 to Day 43
Number of Participants who Experience Anti-AMG 592 Antibodies Formation
Up to Day 43
Maximum Observed Serum Concentration (Cmax) of AMG 592
Day 1 up to Day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Arm 1: AMG 592 Dose 1EXPERIMENTALParticipants will receive AMG 592 dose 1 subcutaneously
Arm 2: AMG 592 Dose 2EXPERIMENTALParticipants will receive AMG 592 dose 2 subcutaneously
Arm 3: PlaceboPLACEBO_COMPARATORParticipants will receive placebo subcutaneously
AMG 592: Dose 1EXPERIMENTALAdministered as a single dose subcutaneous (SC) injection.
AMG 592: Dose 2EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 3EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 4EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 5EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 6EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 7EXPERIMENTALAdministered as a single dose SC injection.
AMG 592: Dose 8EXPERIMENTALAdministered as a single dose SC injection.
PlaceboPLACEBO_COMPARATORAdministered as SC injection.
Interventions
NameTypeDescription
AMG 592DRUGAdministered as SC injection
PlaceboOTHERAdministered as SC injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage) * Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m\^2 at the time of scree...

Countries:AustraliaUnited States
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