Study to Evaluate HZN-457 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: HZN-457

• Registration Number: NCT05565768
• Lead Sponsor: Horizon Therapeutics Ireland DAC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Study Start: 2022-11-22
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
HZN-457	HZN-457	-

Primary Outcome Measures

Name	Time	Method
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 Body Temperature values.	Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG QRS values.	Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in Pulse Rate values.	Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG QT values.	Baseline, Day 1 Post-Dose, Day 2, Day 4
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 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
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 Urinalysis 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 Prothrombin 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 Respiratory Rate values.	Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG PR 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 Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax)	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
Time to peak plasma concentration (Tmax)	Day 1 to Day 8
Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing	Day 1 to Day 337

Trial Locations

Locations (1)

New Zealand Clinical Research; 🇳🇿 Christchurch, New Zealand