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HZN-457

Phase 1

Undisclosed | Small molecule | Other |Amgen Inc.|Trials Updated: Sep 7, 2023

HZN-457 development status

Highest phase Phase 1

Registered trials 1 across 1 sponsor since Oct 2022

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

HZN-457 clinical trials

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 drug being developed by Amgen Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who is developing HZN-457?

HZN-457 is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program for this investigational small molecule.

What phase is HZN-457 in?

HZN-457 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is HZN-457 in?

HZN-457 has been evaluated in one completed Phase 1 trial, NCT05565768, titled Study to Evaluate HZN-457 in Healthy Volunteers. That trial enrolled 36 healthy adult participants in New Zealand and used a randomized, double-blind, placebo-controlled design.

What type of drug is HZN-457?

HZN-457 is a small molecule therapeutic candidate. It was tested in a randomized, double-blind, placebo-controlled Phase 1 study of 36 healthy volunteers, which is a typical early-stage design for assessing a new small molecule in humans.

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