Study to Evaluate HZN-457 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-08-09

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HZN-457

Group Type EXPERIMENTAL

HZN-457

Intervention Type DRUG

HZN-457 will be given in one subcutaneous administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be given in one subcutaneous administration

Interventions

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HZN-457

HZN-457 will be given in one subcutaneous administration

Intervention Type DRUG

Placebo

Placebo will be given in one subcutaneous administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes