ACTRN12614000681651已完成1 期
A Placebo-Controlled Trial to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of ALD403, a Humanized Anti-(Calcitonin Gene-Related Peptide) Monoclonal Antibody in Healthy Volunteers
Alder Biopharmaceuticals0 个研究点目标入组 60 人开始时间: 2014年6月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception
- •Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures
- •Normal renal function as calculated by the Cockcroft-Gault equation at screening
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive
- •No history or presence of any other medical illness Ex-smoker (>6 months from quitting) or non-smoker
- •Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed
排除标准
- •History of febrile illness within 5 days prior to dosing
- •Clinically significant laboratory findings
- •Any ongoing co-morbidity or dermatological condition The presence of tattoos on the forearm, chest, or abdominal region Any medical condition that could put the patient at increased risk with exposure to an anti-CGRP antibody such as pre-existing cardiovascular (hypertension, ischemic heart disease), cerebrovascular disease, diabetes, or Raynaud’s disease
- •Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to screening visit. Subjects must be willing to refrain from unusually strenuous exercise for the duration of the trial
- •Hospitalization for any reason within 30 days of the screening visit
- •History of or positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), and/or Hepatitis C antibody (HCV) at screening
- •History of malignancy other than adequately treated carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to screening
- •History of past or current habitual drug abuse, including alcohol abuse History of rubber/latex allergy, or allergy to medical adhesives
- •History of capsaicin allergy
- •Known sensitivity to any of the components of the Investigational Product formulation
- •Receipt of any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or 5 plasma half-lives (whichever is longer) before dosing
- •Receipt of monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
研究者
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