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临床试验/ACTRN12622001020774
ACTRN12622001020774已完成1 期

A Randomized, Positive- and Placebo-Controlled Study to Evaluate the Effects of ONC201 on Cardiac Repolarization in Healthy Participants - Part 2

Chimerix, Inc.0 个研究点目标入组 30 人开始时间: 2022年7月21日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30

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
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 45 Years(—)
性别
All

入选标准

  • Male or female between 18 to 45 years of age
  • Female must be of non-childbearing potential
  • Body weight greater than 50 kg, body mass index between 18-30 kg/m2
  • Healthy Volunteers who are overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, PE, laboratory tests, vital signs, and cardiac monitoring.

排除标准

  • Have a positive serological test result at the screening evaluation consistent with possible infection with HBV, HCV, or HIV.
  • Have a positive pregnancy test at screening or Period 1 Day -1
  • Current history of moderate to heavy tobacco/nicotine use
  • Abnormal 12-lead ECG at Screening or Period 1 Day -1,
  • Resting supine heart rate less than 45 beats per minute or greater than 100 beats per minute
  • Any clinically significant abnormal findings during physical examination or medical history

研究者

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