ISRCTN63295298进行中（未招募）1 期
A Phase I randomized, investigator/participant-blind, adaptive, single ascending dose, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and food effects of RO7308480 following oral administration in healthy participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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. 18 to 55 years of age inclusive, at the time of signing the informed consent
- •2. Male and female participants who are overtly healthy (defined by the absence of evidence of any active or chronic disease) as determined by medical evaluation
- •3. Participants able to communicate with the study staff
- •4. Body mass index (BMI) of 18 to 30 kg/m² inclusive
排除标准
- •1. Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study
- •2. Use of any psychoactive medication, or medications known to have effects on central nervous system (CNS) or blood flow taken within 4 weeks prior to first dosing
- •3. History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis)
- •4. Any major illness within one month before the screening examination (e.g., COVID-19 infection) or any febrile illness within 1 week prior to screening and up to first study drug administration
- •5. Clinically significant abnormalities in laboratory test results
- •6. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- •7. Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts
- •8. Participants likely to need concomitant medication during the study period
- •9. Use of isotretinoin within 2 years prior to screening
- •10. Incomplete SARS-CoV-2/COVID-19 vaccinations scheme 2 weeks prior to administration of the first dose
- •11. Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the day of follow-up from the previous study, or more than four times a year
- •12. Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •13. Positive result on hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening or within 3 months prior to starting study treatment
- •14. Any suspicion or history of alcohol abuse
- •15. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that contraindicates the participation in the study
- •16. Participants who regularly smoke more than 5 cigarettes daily or equivalent amount of tobacco and nicotine substitutes as determined by history, and unable or unwilling not to smoke during the in-house period
研究者
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