SK-5307 P I single-dose study.

JRCT ID: jRCT2071220045

Registered date:26/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult subjects
• Date of first enrollment: 07/09/2022
• Target sample size: 38
• Study type: Interventional

Intervention(s)

Japanese: Single dose of SK-5307 or placebo in increasing doses
Caucasian: Single dose of SK-5307

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Male

Include criteria

1. Subjects aged 18 years or older but less than 45 years (at the time of informed consent).
2. Subjects with BMI (weight (kg)/[height (m)]2) in the following ranges (at the time of screening).
2-1. Japanese healthy adult males: 18.5 to less than 25.0
2-2. Caucasian healthy adult males: 18.0 to less than 30.0
3. Subjects considered eligible for this study based on the results of screening examination by the investigator or sub-investigator.
4. Subjects who have the capacity to consent and whose written consent has been obtained from the subject.

Exclude criteria

Subjects with current medical history.
2. Subjects with a history of liver disease, renal disease, cardiovascular disease, hematological disease, endocrine system disease, digestive system disease, respiratory system disease, psychiatric or cranial nerve disease (including epilepsy), infectious disease that the investigator or sub-investigator judges to affect the safety of the subject or the evaluation of the investigational drug.
3. Subjects with clinically abnormalities in the screening or 12-lead electrocardiogram at rest on the day of admission.
4. Subjects with a complication or a history of drug dependence or alcohol dependence.
5. Subjects with a complication or a history of drug hypersensitivity.
6. Subjects with a complication or a history of food allergy.
7. Subjects who had an average of 20 grams or more of alcohol per day.
8. Subjects who used any drug or supplement within 2 weeks prior to hospitalization for this study.
9. Subjects who had food or beverages containing grapefruit (juice or pulp) within 3 days prior to hospitalization for this study.
10. Subjects who had ingested food or beverages containing St. John's wort (St. John's wort) within 1 week prior to hospitalization to the study.
11. Subjects who have donated 400 mL whole blood within 12 weeks prior to hospitalization in this study, 200 mL whole blood within 4 weeks, or blood component(plasma component, platelet component) within 2 weeks.
12. Subjects who had a positive result for HIV antigen/antibody, HBs antigen, or HCV antibody, or a positive reaction to syphilis serology or urine drug test at screening.
13. Subjects with a positive for SARS-CoV-2 nucleic acid amplification test on the day of admission.
14. Subjects with symptoms of suspected COVID-19 (novel coronavirus infection).
15. Subject who is in the opinion of the investigator or sub-investigator, unsuitable in any other way to participate in this study.

Related Information

• Primary Sponsor: Kenji Asano