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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05565768