临床试验/NCT02230228

NCT02230228已完成1 期

A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers

Alkeus Pharmaceuticals, Inc.0 个研究点目标入组 40 人开始时间: 2014年4月最近更新: 2025年4月27日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Alkeus Pharmaceuticals, Inc.
入组人数: 40
主要终点: Safety of 4-week daily dosing of ALK-001 in healthy adults.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 21 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

•Subject has taken disallowed items during the past 30 days
•Female with a positive urine pregnancy test at screening
•Lactating woman
•Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days
•History or current evidence of gastrointestinal malabsorption
•Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study
•Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.

研究组 & 干预措施

ALK-001 capsules

Experimental

干预措施: ALK-001 (No generic name) (Drug)

结局指标

主要结局

Safety of 4-week daily dosing of ALK-001 in healthy adults.

时间窗: 4 weeks

Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire).

次要结局

未报告次要终点

研究者

发起方

Alkeus Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

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