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HZN-457

Phase 1

Healthy | Small molecule | Other |Amgen Inc.|Last Updated: Sep 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC

Total Trials1

Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

HZN-457 · 1 trial · 1 indication

Phase 1 1

NCT05565768Study to Evaluate HZN-457 in Healthy VolunteersHealthy

COMPLETED36 Analytics

PHASE1COMPLETED

Study to Evaluate HZN-457 in Healthy Volunteers

Healthy

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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

Arm	Type	Description
HZN-457	EXPERIMENTAL	-
Placebo	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
HZN-457	DRUG	HZN-457 will be given in one subcutaneous administration
Placebo	DRUG	Placebo will be given in one subcutaneous administration

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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about HZN-457

What is HZN-457?

HZN-457 is an investigational small molecule being developed by Amgen Inc. (AMGN). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains in clinical testing.

What is HZN-457 used for?

HZN-457 is being studied in healthy volunteers as part of early clinical development. Its intended therapeutic use has not been established, as it is still in Phase 1 trials.

Who makes HZN-457?

HZN-457 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is HZN-457 in?

HZN-457 is in Phase 1 clinical development. A Phase 1 study in healthy volunteers has been completed, but the drug is still investigational and not yet approved for any use.

What clinical trials is HZN-457 in?

HZN-457 has one completed Phase 1 trial, NCT05565768, which evaluated the drug in 36 healthy volunteers in New Zealand. The study was randomized, double-blind, and placebo-controlled.

Is HZN-457 FDA approved?

HZN-457 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with a completed study in healthy volunteers. Approval status has not been established.