ACTRN12615000531516已完成1 期
A Multiple Dose, 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 BioPharmaceuticals, Inc.0 个研究点目标入组 60 人开始时间: 2015年5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
- •1.Healthy females and males 18 to 65 years of age inclusive
- •2.Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or oral contraceptive, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm) or exercise abstinence during and for at least 6 months after the last dose of study drug. Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before trial start
- •3.Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures
- •4.Normal renal function as calculated by the Cockcroft-Gault equation at screening
- •5.No history or presence of any other medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude trial participation
排除标准
- •1.Women who are pregnant, planning to become pregnant, or breastfeeding
- •2.Clinically significant laboratory findings showing evidence of organ dysfunction, any clinically significant deviation from the normal range, or clinically significant physical exam abnormalities at screening, as evaluated by the Investigator
- •3.Any ongoing co-morbidity or dermatological condition (e.g., psoriasis, eczema, severe acne requiring treatment) that in the opinion of the Investigator will interfere with the evaluation and participation in the trial
- •4.The presence of tattoos on the forearm, chest, or abdominal region that could interfere with the evaluation of safety and study endpoints in the trial
- •5.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
- •6.Use of any concomitant medications within 14 days of dosing, unless authorized by the Sponsor and/or PI
- •7.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
- •8.12-lead ECG demonstrating QTcF > 450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility
- •9.Hospitalization for any reason within 30 days of the screening visit
- •10.History of or positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), and/or Hepatitis C antibody (HCV) at screening
- •11.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
- •12.History of past or current habitual drug abuse, including alcohol abuse or positive urine drugs of abuse result at screening
- •13.History of capsaicin allergy
- •14.Less than or equal to 50% Increase in perfusion (skin blood flow) following topical capsaicin challenge relative to vehicle challenge at screening
- •15.Known sensitivity to any of the components of the Investigational Product formulation
- •16.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
- •17.Receipt of monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) or previous treatment with ALD403
- •18.Planned or current participation in any other clinical trial during this clinical trial
研究者
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