Study to Evaluate HZN-457 in Healthy Volunteers

NCT05565768 | Completed Phase 1 DMC

• 1 other identifier: HZNP-HZN-457-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (19)

• Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).

  Day 1 up to Day 337

• Change from Baseline in Hemoglobin value.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in white blood cell counts.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in platelet counts.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Prothrombin Time.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Activated Partial Thromboplastin Time.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

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

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

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

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Urinalysis values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Systolic Blood Pressure values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Diastolic Blood Pressure values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Pulse Rate values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Respiratory Rate values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in Body Temperature values.

  Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85

• Change from Baseline in ECG Heart Rate values.

  Baseline, Day 1 Post-Dose, Day 2, Day 4

• Change from Baseline in ECG PR values.

  Baseline, Day 1 Post-Dose, Day 2, Day 4

• Change from Baseline in ECG QRS values.

  Baseline, Day 1 Post-Dose, Day 2, Day 4

• Change from Baseline in ECG QT values.

  Baseline, Day 1 Post-Dose, Day 2, Day 4

• Change from Baseline in ECG QTc values.

  Baseline, Day 1 Post-Dose, Day 2, Day 4

Secondary Outcomes (6)

• Peak plasma concentration (Cmax)

  Day 1 to Day 8

• Time to peak plasma concentration (Tmax)

  Day 1 to Day 8

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

  Day 1 to Day 8

• Elimination half-life (t1/2)

  Day 1 to Day 8

• Fraction of the administered dose excreted into the urine (Fe)

  Day 1 to Day 2

Study Arms (2)

HZN-457

EXPERIMENTAL

Drug: HZN-457

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HZN-457 DRUG

HZN-457 will be given in one subcutaneous administration

HZN-457

Placebo DRUG

Placebo will be given in one subcutaneous administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horizon Therapeutics Ireland DAC: lead

Study Sites (2)

New Zealand Clinical Research

Auckland, New Zealand

Location

New Zealand Clinical Research

Christchurch, New Zealand

Location

Study Officials

• Horizon Medical Director

  Horizon Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 4, 2022
• Study Start: November 22, 2022
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

NZ (2)