A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM9528

Inclusion Criteria:

The participant must meet all the following criteria to be included in the study:

1. Male, ≥18 and ≤65 years of age.
2. BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for male.
3. Non-smokers (no use of tobacco or nicotine products from 3 months prior to screening through the EOS visit).
4. Healthy as defined the current protocol.
5. Male participant who are not vasectomized for at least 3 months prior to dosing, and who are sexually active with a female partner of childbearing potential must be willing to use the acceptable contraceptive methods as defined the current protocol from the first dose and for 90 days after the last dose.
6. Male participant (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
7. Male participant must be willing not to donate sperm for 90 days after the last dose.
8. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria:

Participant for whom any of the following applies will be excluded from the study:

1. The participant had current evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
2. Any clinically significant abnormal finding at physical examination.
3. The participant had any condition possibly affecting drug absorption.
4. Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
5. The participant had supine blood pressure (BP) >140 mm Hg (systolic) or >90 mm Hg (diastolic) following at least 5 minutes of supine rest.
6. The participant has HR less than 50 or over 100 bpm.
7. The participant had 12-lead ECG demonstrating corrected QT interval by Fridericia (QTcF) >450 msec or a QRS interval >120 msec at screening.
8. The participant had any of the abnormalities as defined the current protocol in clinical laboratory tests at screening.
9. C-SSRS score above Type 1 ideation at Screening.
10. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antibody at Screening.
11. Positive urine drug screen, urine cotinine test, or urine alcohol test.
12. History of significant allergic reactions to any drug.
13. History of any central nervous system (CNS) disorder or history of seizure of any cause.
14. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening.
15. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week or who are unwilling to abstain from alcohol during the study.
16. History of active tuberculosis or presence of active or latent tuberculosis at Screening.
17. History of clinically significant opportunistic infection.
18. History of serious local infection or systemic infection within 3 months prior to screening.
19. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety.
20. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
21. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
22. Participant who consumed excessive amounts of tea, coffee, or caffeine-containing beverages within 3 months prior to screening, or who are unwilling to abstain from coffee during the study.
23. Participant who have consumed specific foods/beverages within 48 hours prior to dosing.
24. The participant had a history of cancer with the exception of adequately treated basal cell or squamous cell carcinoma of the skin.
25. Withdrawal of the hand before 15 seconds of immersion or after 120 seconds in the cold water bath in any cold pressor test during the Screening familiarization sessions.
26. The Lower PTT < 50% of the higher PTT in the second and third CPT assessments among the three cold pressor tests performed during Screening.
27. Participant who have difficulty in venous blood collection or have a history of needle and blood fainting.
28. Participant with dysphagia, or who are unable to swallow the study drug whole as judged by the investigator.
29. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.