HealthyPhase 1NCT05565768
Study to Evaluate HZN-457 in Healthy Volunteers
A Phase 1 study testing HZN-457 in people with Healthy, run by Horizon Therapeutics Ireland DAC at 2 sites in New Zealand.
Trial summary
The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HZN-457
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 22 Nov 2022to 9 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
New Zealand Clinical Research
Auckland
New Zealand Clinical Research
Christchurch
About this study
Official 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
The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
- Conditions
- Healthy
- Being tested
- HZN-457, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZN-457Drug
HZN-457 will be given in one subcutaneous administration
PlaceboDrug
Placebo will be given in one subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| HZN-457 | Experimental | Not described Receives: Drug: HZN-457 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).
Measured: Day 1 up to Day 337
Change from Baseline in Hemoglobin value.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in white blood cell counts.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in platelet counts.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Prothrombin Time.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Activated Partial Thromboplastin Time.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Aspartate Aminotransferase (AST) value.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Alanine Aminotransferase (ALT) value.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Urinalysis values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Systolic Blood Pressure values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Diastolic Blood Pressure values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Pulse Rate values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Respiratory Rate values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Body Temperature values.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG Heart Rate values.
Measured: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG PR values.
Measured: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QRS values.
Measured: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QT values.
Measured: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QTc values.
Measured: Baseline, Day 1 Post-Dose, Day 2, Day 4
Secondary outcomes (6)
Peak plasma concentration (Cmax)
Measured: Day 1 to Day 8
Time to peak plasma concentration (Tmax)
Measured: Day 1 to Day 8
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Measured: Day 1 to Day 8
Elimination half-life (t1/2)
Measured: Day 1 to Day 8
Fraction of the administered dose excreted into the urine (Fe)
Measured: Day 1 to Day 2
Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing
Measured: Day 1 to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start22 Nov 2022
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Therapeutics Ireland DAC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horizon Medical Director, Study director, Horizon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565768
- Sponsor's protocol ID
- HZNP-HZN-457-101
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05565768
- Acronym / sponsor ID
- HZNP-HZN-457-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Horizon Therapeutics Ireland DACIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HZN-457 | Experimental | Drug: HZN-457 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HZN-457HZN-457 will be given in one subcutaneous administration | Drug | HZN-457 |
| PlaceboPlacebo will be given in one subcutaneous administration | Drug | Placebo |
Primary outcome
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
Change from Baseline in Hemoglobin value.
Time frame: 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
Change from Baseline in platelet counts.
Time frame: 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
Change from Baseline in Activated Partial Thromboplastin Time.
Time frame: 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
Change from Baseline in Alanine Aminotransferase (ALT) value.
Time frame: 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
Change from Baseline in Systolic Blood Pressure values.
Time frame: 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
Change from Baseline in Pulse Rate values.
Time frame: 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
Change from Baseline in Body Temperature values.
Time frame: 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
Change from Baseline in ECG PR values.
Time frame: 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
Change from Baseline in ECG QT values.
Time frame: 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
6 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: Day 1 to Day 8
Time to peak plasma concentration (Tmax)
Time frame: 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
Elimination half-life (t1/2)
Time frame: Day 1 to Day 8
Fraction of the administered dose excreted into the urine (Fe)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horizon Medical Director study director
Horizon Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HZN-457 in people with Healthy, run by Horizon Therapeutics Ireland DAC at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.