A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects

Theravance Biopharma1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2013年10月最近更新: 2021年1月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Theravance Biopharma
入组人数: 48
试验地点: 1
主要终点: Number of adverse events

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研究点记录与标识符相似试验

研究概览

简要总结

TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
•Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.
•Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

排除标准

•Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
•Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
•Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
•Subject has previously participated in a trial for TD-1607.