Evaluation of the effects of interval between lumbar punctures on cerebrospinal fluid and blood analytes in healthy volunteers

Genentech0 个研究点目标入组 40 人开始时间: 2023年9月15日最近更新: 2023年12月19日

适应症

试验速览

暂无简介。

•1. Participants must have a total body weight between 45 and 120 kilograms (kg), inclusive
•2. Good health, demonstrated by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs
•3. Agreement not to have any additional blood draws or CSF sampling for the duration of the study
•4. No contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation, thrombocytopenia, prior lumbar spinal surgery, abnormal brain imaging, or other factor that precludes safe LP in the opinion of the investigator

•1. Treatment with any vaccine within 14 days prior to Day 1 or vaccination scheduled to occur during the study
•2. Poor peripheral venous access
•3. History of seizures, with the exception of childhood febrile seizures
•4. History of prior traumatic brain injury graded as moderate or severe
•5. Abnormal brain imaging findings that preclude safe LP
•6. History of schizophrenia, schizoaffective disorder, or bipolar disorder
•7. History of malignancy
•8. Positivity for tuberculosis (TB) during screening or within 3 months prior to screening
•9. Positive human immunodeficiency virus (HIV) test at screening
•10. Positive hepatitis B surface antigen (HBsAg) test at screening
•11. Positive hepatitis C virus (HCV) antibody test at screening

发起方