| Eligibility |
Inclusion Criteria:
Informed Consent
1. Able and willing to provide written informed consent and to comply with the study
protocol according to ICH and local regulations
Age
2. Aged from 25 to to 55 years at the time of dosing
Type of Participants and Disease Characteristics
3. Overtly healthy (defined by absence of evidence of any active or chronic disease) as
determined by medical evaluation including:
- A detailed medical and surgical history
- A complete physical and neurological examination
- Vital signs
- 12-lead ECG
- Hematology
- Coagulation
- Blood chemistry
- Serology and urinalysis
4. Fluent in the language of the Investigator and study staff, and able to communicate
with the study staff
Weight
5. Body mass index (BMI) of = 18 to = 30 kg/m2 at screening
Sex
6. Male participants only who, for 3 months after the dosing of RO7248824, agree to:
- Remain abstinent (refrain from heterosexual intercourse) or use contraceptive
barrier measures such as a condom, with a female partner of childbearing
potential, or pregnant female partner, to avoid exposing the embryo
- Refrain from donating sperm
Exclusion Criteria:
Medical Conditions
1. Any condition or disease detected during the medical interview/physical examination
that would render the participant unsuitable for the study, place the participant at
undue risk or interfere with the ability of the participant to complete the study, as
determined by the Investigator
2. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, hematological, or neurological disorders capable of significantly altering
the absorption, metabolism, or elimination of drugs; constituting a risk when taking
the study treatment; or interfering with the interpretation of data
3. History or presence of clinically significant cardiovascular disease in the opinion of
the Investigator
4. History or presence of an abnormal ECG that is clinically significant in the
Investigator's opinion
5. Uncontrolled arrhythmias or history of clinically significant arrhythmias
6. Confirmed abnormal blood pressure
7. Abnormal pulse rate
8. Abnormalities in brain and
9. Evidence or history of clinically significant back pain, back pathology and/or back
injury
10. Evidence or history of significant active bleeding or coagulation disorder
11. Allergy to lidocaine (Xylocaine) or its derivatives
12. Medical or surgical conditions for which LP or associated procedures is
contraindicated
13. Alanine transaminase (ALT) and bilirubin > 1.5 x upper limit of normal (ULN)
14. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
15. History of convulsions or history of loss of consciousness
16. Sensitivity to any of the study treatments, or components thereof, or drug or other
allergy that, in the opinion of the Investigator, contraindicates the participation in
the study
17. Any major illness within one month before the screening examination or any febrile
illness within one week prior to screening and up to first study drug administration
18. Clinically significant abnormalities in laboratory test results
Prior/Concomitant Therapy
19. Used or intends to use any prohibited medications
20. Likely to need concomitant medication during the study period
Prior/Concurrent Clinical Study Experience
21. Participating in an investigational drug or device study within 60 days prior to
screening, as calculated from the day of follow-up from the previous study, or more
than 4 participations in an investigational drug or device study within a year prior
to dosing
22. Previously (within the past 12 months from dosing) included in medical research and/or
a medical protocol involving PET or radiological investigations, or other exposure to
ionizing radiation, which combined with this study would result in an effective dose
of 10 mSv or more
Diagnostic Assessments
23. Positive test for drugs of abuse or alcohol
24. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment)
25. Evidence of HIV infection and/or positive human HIV antibodies
Other Exclusions
26. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of
drug of abuse or previous history of or treatment for a dependence disorder
27. Regularly smoking more than 5 cigarettes daily or equivalent and unable or unwilling
not to smoke or not to use other nicotine containing products during the in-house
period
28. Donated over 500 mL of blood or blood products or had significant blood loss within 3
months prior to screening
29. Under judicial supervision, guardianship or curatorship
30. Not able to undergo PET, CT, or MRI scans
31. Previous lumbar surgery that is likely, in the opinion of the Investigator or surgical
team, to make IT injection unduly difficult or hazardous
32. Scoliosis or spinal deformity preventing IT injection
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