Study to Evaluate HZN-457 in Healthy Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565768
• Other study ID #: HZNP-HZN-457-101
• Status: Completed
• Phase: Phase 1
• Start date: November 22, 2022
• Est. completion date: August 9, 2023

Study information

• Verified date: September 2023
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 9, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HZN-457
HZN-457 will be given in one subcutaneous administration
• Placebo
Placebo will be given in one subcutaneous administration

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Auckland
New Zealand	New Zealand Clinical Research	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Therapeutics Ireland DAC

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) (injection site reactions (ISRs).		Day 1 up to Day 337
Primary	Change from Baseline in Hemoglobin value.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in white blood cell counts.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in platelet counts.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Prothrombin Time.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Activated Partial Thromboplastin Time.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Aspartate Aminotransferase (AST) value.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Alanine Aminotransferase (ALT) value.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Urinalysis values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Systolic Blood Pressure values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Diastolic Blood Pressure values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Pulse Rate values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Respiratory Rate values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in Body Temperature values.		Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Primary	Change from Baseline in ECG Heart Rate values.		Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary	Change from Baseline in ECG PR values.		Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary	Change from Baseline in ECG QRS values.		Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary	Change from Baseline in ECG QT values.		Baseline, Day 1 Post-Dose, Day 2, Day 4
Primary	Change from Baseline in ECG QTc values.		Baseline, Day 1 Post-Dose, Day 2, Day 4
Secondary	Peak plasma concentration (Cmax)		Day 1 to Day 8
Secondary	Time to peak plasma concentration (Tmax)		Day 1 to Day 8
Secondary	Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)		Day 1 to Day 8
Secondary	Elimination half-life (t1/2)		Day 1 to Day 8
Secondary	Fraction of the administered dose excreted into the urine (Fe)		Day 1 to Day 2
Secondary	Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing		Day 1 to Day 337