Study to Evaluate HZN-457 in Healthy Volunteers

September 6, 2023 updated by: Horizon Therapeutics Ireland DAC

A Phase 1 Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HZN-457 in Healthy Volunteers

The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • New Zealand Clinical Research
      • Christchurch, New Zealand
        • New Zealand Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 by the Investigator.
  • Male participants must refrain from donating sperm and either agree to remain abstinent from heterosexual intercourse OR agree to utilize contraception
  • Female participants must be non-pregnant, non-lactating postmenopausal woman of non-childbearing potential (WONCBP) with a follicle-stimulating hormone (FSH) level in the postmenopausal range (> 40 IU/L)

Exclusion Criteria:

  • History or presence of gout.
  • Use of any prescription medication within 14 days or 5 half-lives prior to dosing
  • Participation in another investigational clinical study (eg, drug, vaccine, invasive device) within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
  • Current liver disease, as determined by alanine transaminase (ALT) or aspartate transaminase (AST) levels > upper limit of normal (ULN) at Screening or Day -1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo will be given in one subcutaneous administration
Experimental: HZN-457
Drug: HZN-457
HZN-457 will be given in one subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).
Time Frame: Day 1 up to Day 337
Day 1 up to Day 337
Change from Baseline in Hemoglobin value.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in white blood cell counts.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in platelet counts.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Prothrombin Time.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Activated Partial Thromboplastin Time.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Aspartate Aminotransferase (AST) value.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Alanine Aminotransferase (ALT) value.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Urinalysis values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Systolic Blood Pressure values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Diastolic Blood Pressure values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Pulse Rate values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Respiratory Rate values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Body Temperature values.
Time Frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG Heart Rate values.
Time Frame: Baseline, Day 1 Post-Dose, Day 2, Day 4
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG PR values.
Time Frame: Baseline, Day 1 Post-Dose, Day 2, Day 4
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QRS values.
Time Frame: Baseline, Day 1 Post-Dose, Day 2, Day 4
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QT values.
Time Frame: Baseline, Day 1 Post-Dose, Day 2, Day 4
Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QTc values.
Time Frame: Baseline, Day 1 Post-Dose, Day 2, Day 4
Baseline, Day 1 Post-Dose, Day 2, Day 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Peak plasma concentration (Cmax)
Time Frame: Day 1 to Day 8
Day 1 to Day 8
Time to peak plasma concentration (Tmax)
Time Frame: Day 1 to Day 8
Day 1 to Day 8
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Time Frame: Day 1 to Day 8
Day 1 to Day 8
Elimination half-life (t1/2)
Time Frame: Day 1 to Day 8
Day 1 to Day 8
Fraction of the administered dose excreted into the urine (Fe)
Time Frame: Day 1 to Day 2
Day 1 to Day 2
Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing
Time Frame: Day 1 to Day 337
Day 1 to Day 337

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horizon Therapeutics Ireland DAC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Horizon Medical Director, Horizon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HZNP-HZN-457-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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