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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
HZNP-HZN-457-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).
Timepoint [1] 0 0
Day 1 up to Day 337
Primary outcome [2] 0 0
Change from Baseline in Hemoglobin value.
Timepoint [2] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [3] 0 0
Change from Baseline in white blood cell counts.
Timepoint [3] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [4] 0 0
Change from Baseline in platelet counts.
Timepoint [4] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [5] 0 0
Change from Baseline in Prothrombin Time.
Timepoint [5] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [6] 0 0
Change from Baseline in Activated Partial Thromboplastin Time.
Timepoint [6] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [7] 0 0
Change from Baseline in Aspartate Aminotransferase (AST) value.
Timepoint [7] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [8] 0 0
Change from Baseline in Alanine Aminotransferase (ALT) value.
Timepoint [8] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [9] 0 0
Change from Baseline in Urinalysis values.
Timepoint [9] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [10] 0 0
Change from Baseline in Systolic Blood Pressure values.
Timepoint [10] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [11] 0 0
Change from Baseline in Diastolic Blood Pressure values.
Timepoint [11] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [12] 0 0
Change from Baseline in Pulse Rate values.
Timepoint [12] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [13] 0 0
Change from Baseline in Respiratory Rate values.
Timepoint [13] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [14] 0 0
Change from Baseline in Body Temperature values.
Timepoint [14] 0 0
Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary outcome [15] 0 0
Change from Baseline in ECG Heart Rate values.
Timepoint [15] 0 0
Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary outcome [16] 0 0
Change from Baseline in ECG PR values.
Timepoint [16] 0 0
Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary outcome [17] 0 0
Change from Baseline in ECG QRS values.
Timepoint [17] 0 0
Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary outcome [18] 0 0
Change from Baseline in ECG QT values.
Timepoint [18] 0 0
Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary outcome [19] 0 0
Change from Baseline in ECG QTc values.
Timepoint [19] 0 0
Baseline, Day 1 Post-Dose, Day 2, Day 4
Secondary outcome [1] 0 0
Peak plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 to Day 8
Secondary outcome [2] 0 0
Time to peak plasma concentration (Tmax)
Timepoint [2] 0 0
Day 1 to Day 8
Secondary outcome [3] 0 0
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Timepoint [3] 0 0
Day 1 to Day 8
Secondary outcome [4] 0 0
Elimination half-life (t1/2)
Timepoint [4] 0 0
Day 1 to Day 8
Secondary outcome [5] 0 0
Fraction of the administered dose excreted into the urine (Fe)
Timepoint [5] 0 0
Day 1 to Day 2
Secondary outcome [6] 0 0
Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing
Timepoint [6] 0 0
Day 1 to Day 337

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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2023
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Horizon Therapeutics Ireland DAC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05565768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Horizon Medical Director
Address 0 0
Horizon Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05565768