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HZN-457

Phase 1

Healthy | Small molecule | Other |Amgen Inc.|Last Updated: Sep 7, 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
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05565768Study to Evaluate HZN-457 in Healthy VolunteersPHASE1 COMPLETED 36 — — Nov 22, 2022Aug 9, 2023Sep 7, 20232 New Zealand
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).
Day 1 up to Day 337
Change from Baseline in Hemoglobin value.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in white blood cell counts.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in platelet counts.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Prothrombin Time.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Activated Partial Thromboplastin Time.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Aspartate Aminotransferase (AST) value.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Alanine Aminotransferase (ALT) value.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Urinalysis values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Systolic Blood Pressure values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Diastolic Blood Pressure values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Pulse Rate values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Respiratory Rate values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Body Temperature values.
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG Heart Rate values.
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG PR values.
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QRS values.
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QT values.
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QTc values.
Baseline, Day 1 Post-Dose, Day 2, Day 4
Secondary Endpoints
Peak plasma concentration (Cmax)
Day 1 to Day 8
Time to peak plasma concentration (Tmax)
Day 1 to Day 8
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Day 1 to Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
HZN-457EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
HZN-457DRUGHZN-457 will be given in one subcutaneous administration
PlaceboDRUGPlacebo will be given in one subcutaneous administration
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Screening serum uric acid (sUA) ≥ 4 mg/dL (238 µmol/L) * Screening body mass index (BMI) between 20 to 34.0 kg/m2, inclusive * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG findings, as deemed b...

Countries:New Zealand
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