NCT03146416已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit.
- •Japanese subjects must:
- •Be first generation Japanese, defined as born in Japan and both biologic parents are ethnic Japanese
- •Have maintained a Japanese lifestyle that has not significantly changed since leaving Japan, including having access to Japanese food and adhering to a Japanese diet.
- •Caucasian subjects must be Caucasian of European or Latin American descent
- •Modest elevations in LDL-C (≥100 mg/dL, but <160 mg/dL)
排除标准
- •Significant concomitant illness
- •Known allergy or sensitivity to monoclonal antibodies (mAbs)
- •Previous exposure to anti-ANGPTL3 antibody
- •Body mass index (BMI) >35 kg/m2 at the screening visit
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Cohort 2
Experimental
Low dose regimen: evinacumab IV or placebo IV
干预措施: Placebo (Drug)
Cohort 1
Experimental
Evinacumab SC or placebo SC
干预措施: Evinacumab (Drug)
Cohort 1
Experimental
Evinacumab SC or placebo SC
干预措施: Placebo (Drug)
Cohort 2
Experimental
Low dose regimen: evinacumab IV or placebo IV
干预措施: Evinacumab (Drug)
Cohort 3
Experimental
High dose regimen: evinacumab IV or placebo IV
干预措施: Evinacumab (Drug)
Cohort 3
Experimental
High dose regimen: evinacumab IV or placebo IV
干预措施: Placebo (Drug)
Cohort 4
Experimental
Evinacumab or placebo SC every week (QW) x 8 doses
干预措施: Evinacumab (Drug)
Cohort 4
Experimental
Evinacumab or placebo SC every week (QW) x 8 doses
干预措施: Placebo (Drug)
Cohort 5
Experimental
Evinacumab or placebo SC x 1 dose
干预措施: Evinacumab (Drug)
Cohort 5
Experimental
Evinacumab or placebo SC x 1 dose
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to week 31
Severity of TEAEs
时间窗: Baseline up to week 31
次要结局
- Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax)(Up to Week 31)
- PK parameters of evinacumab for geometric means of Area under the curve (AUC) computed from time zero to the last measurable concentration (AUClast)(Up to Week 31)
- PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau)(Up to Week 31)
- Ratio of Japanese versus Caucasian populations for geometric means of Cmax(Up to Week 31)
- Ratio of Japanese versus Caucasian populations for geometric means of AUClast(Up to Week 31)
- Ratio of Japanese versus Caucasian populations for geometric means of AUCtau(Up to Week 31)
- Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)(Up to Week 31)
- Absolute change from baseline over time in the PD variable: Total cholesterol(Up to Week 31)
- Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)(Up to Week 31)
- Absolute change from baseline over time in the PD variable: Triglycerides(Up to Week 31)
- Absolute change from baseline over time in the PD variable: non-HDL-C(Up to Week 31)
- Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)](Up to Week 31)
- Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB](Up to Week 31)
- Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1](Up to Week 31)
- Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3](Up to Week 31)
- Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP](Up to Week 31)
- Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)(Up to Week 31)
- Percent change from baseline over time in the PD variable: LDL-C(Up to Week 31)
- Percent change from baseline over time in the PD variable: Total cholesterol(Up to Week 31)
- Percent change from baseline over time in the PD variable: HDL-C(Up to Week 31)
- Percent change from baseline over time in the PD variable: Triglycerides(Up to Week 31)
- Percent change from baseline over time in the PD variable: non-HDL-C(Up to Week 31)
- Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)](Up to Week 31)
- Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB](Up to Week 31)
- Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1](Up to Week 31)
- Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3](Up to Week 31)
- Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP](Up to Week 31)
- Percent change from baseline over time in the PD variable: Total (ANGPTL3)(Up to Week 31)
- Presence and titer of anti-evinacumab antibodies(Up to Week 31)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)NCT01371305Biogen41
已完成
3 期
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-ConstipationConstipationNCT00936884Bausch Health Americas, Inc.50
进行中（未招募）
3 期
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionGiant Cell ArteritisNCT05380453Novartis Pharmaceuticals151
已完成
1 期
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795Fatty Liver DiseaseNCT04844450Janssen Research & Development, LLC55
进行中（未招募）
2 期
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)Squamous Cell CarcinomaNCT06041802Merck Sharp & Dohme LLC19