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Completed

NCT Number: NCT05565768

Study to Evaluate 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HZN-457

Drug

HZN-457 will be given in one subcutaneous administration

Placebo

Drug

Placebo will be given in one subcutaneous administration

Primary outcomes

  1. 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

  2. Change from Baseline in Hemoglobin value.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  3. Change from Baseline in white blood cell counts.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  4. Change from Baseline in platelet counts.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  5. Change from Baseline in Prothrombin Time.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  6. Change from Baseline in Activated Partial Thromboplastin Time.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  7. Change from Baseline in Aspartate Aminotransferase (AST) value.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  8. Change from Baseline in Alanine Aminotransferase (ALT) value.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  9. Change from Baseline in Urinalysis values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  10. Change from Baseline in Systolic Blood Pressure values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  11. Change from Baseline in Diastolic Blood Pressure values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  12. Change from Baseline in Pulse Rate values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  13. Change from Baseline in Respiratory Rate values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  14. Change from Baseline in Body Temperature values.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

  15. Change from Baseline in ECG Heart Rate values.

    Time frame: Baseline, Day 1 Post-Dose, Day 2, Day 4

  16. Change from Baseline in ECG PR values.

    Time frame: Baseline, Day 1 Post-Dose, Day 2, Day 4

  17. Change from Baseline in ECG QRS values.

    Time frame: Baseline, Day 1 Post-Dose, Day 2, Day 4

  18. Change from Baseline in ECG QT values.

    Time frame: Baseline, Day 1 Post-Dose, Day 2, Day 4

  19. Change from Baseline in ECG QTc values.

    Time frame: Baseline, Day 1 Post-Dose, Day 2, Day 4

Secondary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: Day 1 to Day 8

  2. Time to peak plasma concentration (Tmax)

    Time frame: Day 1 to Day 8

  3. Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

    Time frame: Day 1 to Day 8

  4. Elimination half-life (t1/2)

    Time frame: Day 1 to Day 8

  5. Fraction of the administered dose excreted into the urine (Fe)

    Time frame: Day 1 to Day 2

  6. Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing

    Time frame: Day 1 to Day 337

Sponsors and collaborators

Lead sponsor

Horizon Therapeutics Ireland DAC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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