NL-OMON49835已完成不适用
A Phase 1, Open-label, Single-dose, Randomized, Crossover Study to Assess the Local Tolerability of the Tildrakizumab 200 mg Dose when Delivered as Single Subcutaneous Injection via the 200 mg/2 mL Pre-filled Syringe - Tolerability Study with Tildrakizumab 200 mg Dose
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Almirall
- 入组人数
- 42
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
- •1. Men or women must be between 18 and 60 years, inclusive, at screening.
- •2. Body mass index (BMI) must be between 18.0 and 30.0 kg/m2, inclusive, at
- •3. Subjects must be able to understand and comply with the requirements of the
- •study and communicate with the Investigator.
- •4. Subjects must give a written, signed, and dated informed consent including
- •authorization for Use and Release of Health and Research Information in
- •accordance with institutional and regulatory guidelines before any
- •study-related activity is performed.
- •5. Subjects are in good general health on the basis of medical history,
- •physical examination, clinical laboratory, ECG, and vital signs, as judged by
- •the Investigator.
- •For the complete overview see the protocol
排除标准
- •1. Any condition that could interfere with delivery of medication or
- •interpretation of assessments or significantly impair pain perception at any of
- •the anatomical sites for injection (upper arms, thighs, abdomen).
- •2. History of or current malignancy (excluding successfully treated basal cell
- •carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma
- •with no evidence of recurrence within 5 years or carcinoma in situ of the
- •cervix that has been adequately treated).
- •3. History of or current relevant autoimmune diseases (e.g., lupus-like
- •syndromes).
- •4. Clinically significant skin allergies or active dermatologic disorders.
- •5. Hypersensitivity to the active substance or to any of the excipients of the
- •investigational medicinal product (IMP).
- •For the complete overview see the protocol
研究者
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