A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease

1. Known hypersensitivity, allergy, intolerance, or idiosyncratic reaction to the study intervention, or any of the excipients contained in the intervention formulation. If any history of anaphylaxis or reaction to other agents, discussion with (and approval by) the Investigator and Sponsor is required.

2. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.

3. History of dysphagia or any gastrointestinal disease (including Gilbert's syndrome) that affects the participants ability to swallow and/or affects drug absorption.

4. Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at any time prior to administration of the study intervention if SARS-CoV-2 test is performed.

5. Any clinically significant (at the discretion of the Investigator) abnormalities in laboratory test results. Total bilirubin value up to 1.5 times the upper normal limit of normal can be acceptable if associated with normal conjugated bilirubin value (unless the participant has documented Gilbert's Syndrome).

6. History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency, including autoimmune rheumatic disease.

Note: participants with mild asthma controlled with occasional rescue inhaler only (no chronic therapy; no inhaled corticosteroids), and mild atopic dermatitis controlled with topic emollients only (no topical corticosteroids) are not excluded.

7. Immunization with any live vaccine within 28 days prior to administration of study intervention; or expected to require any live vaccines during study period.

8. Evidence at the initial screening visit of active or prior hepatitis B infection based on serological tests for hepatitis B surface antigen (HbsAg).

9. Positive serological tests for human immunodeficiency virus (HIV) antibody and/or hepatitis C virus (HCV) antibody at the initial screening visit.

10. Blood donation of \>400 mL within 3 months before screening or \>200 mL within 4 weeks before screening or plan to donate blood during study period.

11. Acute or febrile illness within 7 days prior to the first dose of study intervention or participants with evidence of active infection.

12. Evidence of an active or suspected cancer or a history of malignancy within the previous 3 years, except for the following, which did not require systemic therapy and are considered cured: nonmelanoma skin cancer, curatively treated localized prostate cancer, or other in situ cancer.

13. History of drug abuse or a positive drug abuse test result at screening or D-1.

14. History of alcohol abuse or a positive alcohol test result at screening or D-1.

15. Use of prescription medications or herbal remedies within 14 days or 5 elimination half-lives (whichever is longer) of study intervention administration or use of over the counter (OTC) drugs within 7 days of study intervention administration (apart from recommended doses of vitamin/mineral supplements, OTC analgesics, or other agents that have been discussed with and approved by the Investigator and Sponsor). Participants who used recommended doses of paracetamol/ibuprofen for acute conditions (e.g., headache) will not be excluded. Participants who have been on hormone replacement therapy (HRT) or oral contraception for a period of at least 2 months prior to the start of screening will not be excluded from the study, provided the contraceptive or HRT regimen will remain unchanged during the conduct of the study.

16. Use of any known liver enzyme inducer or liver enzyme inhibiting food or beverage (such as all citrus fruits including tangerine, grapefruit, sweet orange, lime, kumquat, citron, orange, lemon, etc., and fruit juices) within 7 days prior to administration.

17. Any major surgery within 6 months before screening, or plan to have a surgery during the study period.

18. Any other conditions that the Investigator considers may affect the participants' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the participants' participation in the test may affect the test results or their own safety.

19. Receipt of another study intervention within 1 month or 5 elimination half-lives (whichever is longer) prior to administration of the study intervention.

20. Abnormal cardiac conditions and ECG:

i. The Fridericia algorithm corrected QT interval (QTcF) of ECG during screening period is \>450 ms for males and \>470 ms for females or is considered abnormal with clinical significance as determined by the Investigator.

ii. Sustained (ie, 3 independent measurements within 30 minutes) HR (pulse) \>100 or \<40 bpm.

iii. Personal and/or family history of congenital long QT syndrome or sudden cardiac death.

21. Pregnant (positive blood or urine pregnancy test at the initial screening visit or D-1).

22. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

23. Unwilling to abstain from smoking or vaping and the consumption of any caffeine or alcohol-containing food or drinks that may influence the drug metabolism from 72 hours before administration to discharge.

A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease

What this study is about

A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease

What this study is about