NL-OMON53409已完成不适用
A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and a4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects - PB016 versus US-licensed and EU-approved Entyvio® Biosimilar Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Sex: male or female.
- •2. Age: 18 years to 65 years, inclusive, at screening.
- •3. Body mass index (BMI): 18.5 kg/m2 to 30.0 kg/m2, inclusive, at screening.
- •4. Status: healthy subjects.
- •5. The subject is healthy at screening as determined by their medical history,
- •physical examination, vital signs, an ECG, and clinical laboratory testing as
- •judged by the Investigator.
- •Further criteria apply
排除标准
- •1. Any known prior exposure to vedolizumab or any other therapeutic mAb or any
- •other B- and T-cell targeting therapies provided with biological drugs 4 months
- •before study.
- •2. Any known exposure to immunosuppressive or immunomodulatory synthetic drugs
- •or other synthetic drugs with known immunosuppressive or immunomodulatory
- •action (eg, methotrexate, cyclosporine, azathioprine, mitoxantrone, tacrolimus)
- •within 3 months before study.
- •3. Known or suspected hypersensitivity to vedolizumab, or any components of the
- •formulation used (citric acid monohydrate, sodium citrate dihydrate,
- •L-histidine, L histidine monohydrochloride, larginine hydrochloride,
- •polysorbate 80).
- •4. Any exposure to steroids within one month prior to dosing, to agents such as
- •interferon-β, glatiramer acetate, fingolimod, or laquinimod within the last 2
- •months, to teriflunomide during the last 3.5 months, or to dimethyl fumarate
- •within 6 months prior to dosing.
- •5. Plasma exchange within 3 weeks prior to dosing.
- •Further criteria apply
研究者
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