NL-OMON48246已完成不适用
An open label study to assess the safety and tolerability of PB006 administered as a single intravenous infusion - PB006 single dose safety study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- bioeq GmbH
- 入组人数
- 10
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 99（—）
入选标准
- •- healthy males and females
- •- 18-65 years, inclusive
- •- BMI: 18.5-32.0 kg/m2
排除标准
- •1. Any known exposure to natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, ofatumumab or obinutuzumab or any other B- and T-cell targeting therapies.
- •2. Any known exposure to immunosuppressive agents (e.g. methotrexate, cyclosporine, azathioprine, mitoxantrone, tacrolimus)
- •3. Known or suspected hypersensitivity to natalizumab, or any components of the formulation used (L-histidine/L-histidine hydrochloride, sodium chloride, polysorbate 80).
- •4. Any exposure to steroids within one month prior to dosing, to agents such as interferon-β, glatiramer acetate, fingolimod laquinimod within the last 2 months, toteriflunomide during the last 3.5 months, or to dimethyl fumarate within 6 months prior to dosing.
- •5. Positive test for anti-JCV antibodies [screening 1].
- •6. Female subject who has been pregnant within 6 months prior to screening 2, or breastfeeding or lactating within 3 months prior to screening 2.
- •7. Any of the liver enzymes (AST, ALT, alkaline phosphatase [ALP],
- •gamma-glutamyltransferase [GGT]) and TBL above the ULN. In such a case the assessment may be repeated once. [Screening 2 and Day-1]
- •8. Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).;Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study.
研究者
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