A Phase 1 Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HZN-457 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from Baseline in Activated Partial Thromboplastin Time.
研究概览
简要总结
The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Current liver disease, as determined by alanine transaminase (ALT) or aspartate transaminase (AST) levels > upper limit of normal (ULN) at Screening or Day -1.
研究组 & 干预措施
HZN-457
干预措施: HZN-457 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Activated Partial Thromboplastin Time.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Body Temperature values.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG QRS values.
时间窗: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in Pulse Rate values.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG QT values.
时间窗: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in Alanine Aminotransferase (ALT) value.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Systolic Blood Pressure values.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Diastolic Blood Pressure values.
时间窗: 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).
时间窗: Day 1 up to Day 337
Change from Baseline in Hemoglobin value.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in white blood cell counts.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in platelet counts.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Urinalysis values.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG Heart Rate values.
时间窗: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in ECG QTc values.
时间窗: Baseline, Day 1 Post-Dose, Day 2, Day 4
Change from Baseline in Prothrombin Time.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Aspartate Aminotransferase (AST) value.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in Respiratory Rate values.
时间窗: Baseline, Day 2, Day 4, Day 8, Day 15, Day 43, Day 85
Change from Baseline in ECG PR values.
时间窗: Baseline, Day 1 Post-Dose, Day 2, Day 4
次要结局
- Time to peak plasma concentration (Tmax)(Day 1 to Day 8)
- 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)
- Change and percent change from baseline in serum uric acid (sUA) evaluated post dosing(Day 1 to Day 337)