NCT03146988已完成1 期
Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult 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
- 150
- 试验地点
- 1
- 主要终点
- Pharmacodynamic parameter: ANC AOBEC0-tlast
研究概览
简要总结
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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 males or non-pregnant, non-lactating healthy females aged 18 to 55 years
- •Body mass index ≥19.0 to ≤30.0 kg/m2
- •Body weight >55 kg"
排除标准
- •Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)
- •Subjects who have received any IMP in a clinical research study within the previous 3 months
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •Current smokers who smoke more than 10 cigarettes per day
- •Positive drugs of abuse test result
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
研究组 & 干预措施
RGB-02 6 mg SC (test product)
Experimental
干预措施: RGB-02 or Neulasta® (pegfilgrastim) (Drug)
Neulasta®
Active Comparator
干预措施: RGB-02 or Neulasta® (pegfilgrastim) (Drug)
结局指标
主要结局
Pharmacodynamic parameter: ANC AOBEC0-tlast
时间窗: 67 days
Pharmacokinetic parameter: AUC0-inf
时间窗: 67 days
Area under the serum concentration vs time curve from dosing to the last measured time point
Pharmacokinetic parameter: Cmax
时间窗: 67 days
Pharmacodynamic parameter: ANCmax
时间窗: 67 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.SchizophreniaNCT04865835Otsuka Pharmaceutical Development & Commercialization, Inc.21
已完成
2 期
PD of VAY736 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeNCT02149420Novartis Pharmaceuticals27
已完成
1 期
A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male VolunteersHealthy VolunteersNCT03293654mAbxience Research S.L.114
已完成
1 期
Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 DiabetesDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT01865292Novo Nordisk A/S40
已完成
1 期
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy SubjectsHealthyNCT04772274Samsung Bioepis Co., Ltd.201