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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05565768
Registration number
NCT05565768
Ethics application status
Date submitted
26/09/2022
Date registered
4/10/2022
Date last updated
7/09/2023
Titles & IDs
Public title
Study to Evaluate HZN-457 in Healthy Volunteers
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Scientific title
A Phase 1 Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HZN-457 in Healthy Volunteers
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Secondary ID [1]
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HZNP-HZN-457-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - HZN-457
Treatment: Drugs - Placebo
Experimental: HZN-457 -
Placebo Comparator: Placebo -
Treatment: Drugs: HZN-457
HZN-457 will be given in one subcutaneous administration
Treatment: Drugs: Placebo
Placebo will be given in one subcutaneous administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).
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Assessment method [1]
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Timepoint [1]
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Day 1 up to Day 337
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Primary outcome [2]
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Change from Baseline in Hemoglobin value.
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Assessment method [2]
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Timepoint [2]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [3]
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Change from Baseline in white blood cell counts.
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Assessment method [3]
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Timepoint [3]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [4]
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Change from Baseline in platelet counts.
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Assessment method [4]
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Timepoint [4]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [5]
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Change from Baseline in Prothrombin Time.
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Assessment method [5]
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Timepoint [5]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [6]
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Change from Baseline in Activated Partial Thromboplastin Time.
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Assessment method [6]
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Timepoint [6]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [7]
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Change from Baseline in Aspartate Aminotransferase (AST) value.
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Assessment method [7]
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Timepoint [7]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [8]
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Change from Baseline in Alanine Aminotransferase (ALT) value.
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Assessment method [8]
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Timepoint [8]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [9]
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Change from Baseline in Urinalysis values.
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Assessment method [9]
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Timepoint [9]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [10]
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Change from Baseline in Systolic Blood Pressure values.
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Assessment method [10]
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Timepoint [10]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [11]
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Change from Baseline in Diastolic Blood Pressure values.
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Assessment method [11]
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Timepoint [11]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [12]
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Change from Baseline in Pulse Rate values.
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Assessment method [12]
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Timepoint [12]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [13]
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Change from Baseline in Respiratory Rate values.
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Assessment method [13]
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Timepoint [13]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [14]
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Change from Baseline in Body Temperature values.
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Assessment method [14]
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Timepoint [14]
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Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
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Primary outcome [15]
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Change from Baseline in ECG Heart Rate values.
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Assessment method [15]
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Timepoint [15]
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Baseline, Day 1 Post-Dose, Day 2, Day 4
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Primary outcome [16]
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Change from Baseline in ECG PR values.
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Assessment method [16]
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Timepoint [16]
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Baseline, Day 1 Post-Dose, Day 2, Day 4
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Primary outcome [17]
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Change from Baseline in ECG QRS values.
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Assessment method [17]
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Timepoint [17]
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Baseline, Day 1 Post-Dose, Day 2, Day 4
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Primary outcome [18]
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Change from Baseline in ECG QT values.
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Assessment method [18]
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Timepoint [18]
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Baseline, Day 1 Post-Dose, Day 2, Day 4
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Primary outcome [19]
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Change from Baseline in ECG QTc values.
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Assessment method [19]
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Timepoint [19]
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Baseline, Day 1 Post-Dose, Day 2, Day 4
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Secondary outcome [1]
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Peak plasma concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Day 1 to Day 8
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Secondary outcome [2]
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Time to peak plasma concentration (Tmax)
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Assessment method [2]
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Timepoint [2]
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Day 1 to Day 8
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Secondary outcome [3]
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Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
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Assessment method [3]
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Timepoint [3]
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Day 1 to Day 8
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Secondary outcome [4]
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Elimination half-life (t1/2)
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Assessment method [4]
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Timepoint [4]
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Day 1 to Day 8
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Secondary outcome [5]
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Fraction of the administered dose excreted into the urine (Fe)
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Assessment method [5]
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Timepoint [5]
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Day 1 to Day 2
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Secondary outcome [6]
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Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing
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Assessment method [6]
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Timepoint [6]
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Day 1 to Day 337
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2023
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Sample size
Target
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Horizon Therapeutics Ireland DAC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this first in human study is to assess safety, pharmacokinetics,
pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05565768
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Horizon Medical Director
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Address
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Horizon Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05565768
Download to PDF