Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects

Inclusion Criteria:

1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 monthsprior to screening) or social smoker (smokers with 1-5 cigarettes a week), AND with anegative urine cotinine test at check-in, ≥18 and ≤55 years of age, with BMI >18.5 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females and a maximumweight of 120 kg.
2. Healthy as defined by:
3. the absence of clinically significant illness and surgery within 4 weeks prior tostudy drug administration.
4. the absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological, psychiatric,gastrointestinal, renal, hepatic, and metabolic disease. A history of migraines,childhood asthma, or non-hospitalized depression would not be consideredclinically significant.
5. Female participants of non-childbearing potential must be:
6. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing)with confirmation by documented follicle-stimulating hormone (FSH) levels ≥ 40mIU/mL; or
7. surgically sterile (bilateral oophorectomy, bilateral salpingectomy,hysterectomy, or tubal ligation) at least 3 months prior to dosing.
8. Sexually active females of childbearing potential and non-sterile males must bewilling to use an acceptable contraceptive method throughout the study as detailed insection 8.1.
9. Able to understand the study procedures and provide signed informed consent toparticipate in the study.

Exclusion Criteria:

1. Any clinically significant abnormal finding at physical examination.
2. Clinically significant abnormal laboratory test results or positive serology testresults for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.
3. Positive pregnancy test or lactating female subject
4. Positive urine drug screen, urine cotinine test, or alcohol breath test (one repeat isallowed).
5. History of significant allergic reactions (e.g., anaphylactic reaction,hypersensitivity, angioedema) to any drug.
6. Clinically significant ECG abnormalities or vital signs abnormalities (systolic BPlower than 90 or over 160 mmHg, diastolic BP lower than 50 or over 95 mmHg, HR lessthan 45 or over 100 bpm, or RR less than 12 or over 22 bpm) at screening.
7. History of drug abuse within 1 year prior to screening or recreational use of softdrugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
8. History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 6 months prior to screening that exceeds 10 units for women or 15 units for menof alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 45 mL ofdistilled alcohol 40%). Low risk level = 10 unites per week for men and women.
9. Use of medications for the timeframes specified below, with the exception of hormonalcontraceptives and medications exempted by the Investigator on a case-by-case basisbecause they are judged unlikely to affect the PK profile of the study drug or subjectsafety (e.g., topical drug products without significant systemic absorption):
10. depot injection or implant within 3 months prior to the first dosing;
11. live attenuated vaccines within 1 month prior to the first dosing;
12. any drug known to induce or inhibit hepatic drug metabolism, including St. John'swort, within 30 days prior to the first dosing;
13. prescription medications within 14 days prior to the first dosing;
14. any other vaccine, including COVID-19 vaccine, within 14 days prior to the firstdosing;
15. over-the-counter (OTC) medications and natural health products (including herbalremedies such as, homeopathic and traditional medicines, probiotics, foodsupplements such as vitamins, minerals, amino acids, essential fatty acids, andprotein supplements used in sports) within 7 days prior to the first dosing, withthe exception of the occasional use of paracetamol (up to 2 g daily).
16. Participation in a clinical research study involving the administration of aninvestigational or marketed drug or device within 30 days or 5 x T1/2 whichever islonger prior to the first dosing, administration of a biological product in thecontext of a clinical research study within 90 days or 5 x T1/2 whichever is longerprior to the first dosing, or concomitant participation in an investigational studyinvolving no drug or device administration.
17. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or moreof whole blood within 8 weeks prior to dosing.
18. Any reason which, in the opinion of the Investigator, would prevent the subject fromparticipating in the study.