NCT02563938已完成1 期
A Phase 1, Randomized, Double-Blind, Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001 in Subjects With Atopic Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allakos Inc.
- 入组人数
- 34
- 主要终点
- Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively
研究概览
简要总结
This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.
详细描述
AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18-30
- •Determined to be in good health
- •Clinical laboratory values within limits of normal values
- •Normal 12-lead ECG
- •Stool sample negative for parasites
- •Non-smoker
- •Consumed an average of no more than 2 drinks per day within 6 months
- •Subjects of reproductive age must use a highly effective method of contraception
- •Positive skin test in certain cohorts
- •Elevated total eosinophil counts in certain cohorts
排除标准
- •Clinically significant medical history conditions or laboratory values
- •Receipt of investigational drug, biologic or medical device within 30 days prior to Screening
- •New drug therapy within 1 week of study drug administration
- •Antihistamine use within 2 weeks prior to Screening
- •Consumption of alcohol within 48 hours of study drug administration
- •Positive urine drug test or cotinine test at Screening or Day -1
- •History, within the last 2 years, of alcohol abuse, illicit drug use, or significant mental illness
- •Demonstration of veins unsuitable for repeated venipuncture or IV infusion
- •Recent treatment with alternative therapies which may confound clinical or laboratory assessments
- •Donation or loss of more than 500 mL of blood within 56 days prior to study drug administration
- •History of malignancy within last 5 years
- •History of severe allergic or anaphylactic reactions
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
AK001
Experimental
Up to six single ascending doses of AK001.
干预措施: AK001 (Drug)
Saline Solution
Placebo Comparator
Saline solution will be administered as a single infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively
时间窗: Within 86 days
次要结局
- Peripheral blood counts for eosinophils and basophils(Within 28 days)
- Serum eosinophilic cationic protein (ECP) and tryptase levels(Within 28 days)
- 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2(Within 28 days)
- Immediate hypersensitivity skin testing(Within 28 days)
研究者
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