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临床试验/ISRCTN15259645
ISRCTN15259645已完成1 期

A phase I, randomized, double-blind, multiple-ascending-dose study to evaluate the safety and pharmacokinetics of GDC-5780 in healthy subjects

F. Hoffmann-La Roche Ltd0 个研究点目标入组 56 人开始时间: 2023年3月7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
56

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age 18 - 65 years at time of signing informed consent form (ICF)
  • 2. Body mass index (BMI) of = 18.5 and < 30 kilograms per metre squared (kg/m^2) at screening
  • 3. Ability to comply with study protocol

排除标准

  • 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of study drug
  • 2. Planned procedure or surgery during the study
  • 3. Positive human immunodeficiency virus (HIV) test at screening
  • 4. Positive hepatitis B surface antigen (HBsAg) test at screening
  • 5. Positive hepatitis C virus (HCV) antibody test at screening
  • 6. Any serious medical condition or abnormality in clinical laboratory tests
  • 7. History of malignancy within 5 years prior to screening
  • 8. Acute illness within 14 days prior to screening
  • 9. Vaccination within 14 days prior to initiation of study drug

研究者

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