Healthy Volunteers Not Applicable
Conditions
Interventions
Cohort A: Participants will undergo a lumbar puncture procedure on Day 1 and another one 3 days later on Day 4.
Cohort B: Participants will undergo a lumbar puncture procedure on Day 1 and another on
Sponsors
Genentech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validity, stability, and variability of CSF analyte values across different inter-LP interval durations measured using the relative and absolute inter-LP differences for CSF analyte values in each cohort using CSF fluid collected during LP on Days 1, 4, 8, 15, and 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with adverse events (AEs), and severity of AEs measured according to Division of AIDS (DAIDS) toxicity scale from screening (Day -28) up to follow-up (Up to Day 30) 2. Stability and variability of plasma and serum analyte values across different inter-LP interval durations measured using the relative and absolute inter-LP differences for plasma or serum analyte values in each cohort using blood samples collected during LP on Days 1, 4, 8, 15 and 29 | — |
Countries
New Zealand
Contacts
Public ContactClinical Trials
Outcome results
None listed