Single dose study of SK-0348

JRCT ID: jRCT2071220001

Registered date:06/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult subjects
• Date of first enrollment: 25/04/2022
• Target sample size: 46
• Study type: Interventional

Intervention(s)

Step P
Single transdermal administration of SK-0348 and placebo.
Step 1-3
Single transdermal administration of SK-0348 or placebo with dose escalation.

Outcome(s)

• Primary Outcome: Safety, pharmacokinetics, and pharmacodynamics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1. Subjects aged 20 years or older but less than 40 years (at the time of informed consent)
2. Subjects with BMI (weight (kg)/[height (m)]2) of 18.5 to less than 25.0 (at the time of screening)
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 have obtained written consent from the subject.

Exclude criteria

1. Subjects with current medical history.
2. Subject with a history of eye, hepatic, renal, cardiovascular, hematologic, endocrine, gastrointestinal, respiratory, urologic, psychiatric, or neurological disease, xerostomia, or 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 skin conditions as follows.
1) Skin diseases such as eczema, dermatitis, pigmentary abnormalities, etc.
2) With a history of atopic dermatitis.
3) Have skin hypersensitivity.
4) With abnormality at the site of administration of the investigational drug.
4. Subjects with clinically abnormalities in the screening test or 12-lead electrocardiogram at rest on the day of admission.
5. Subjects who have body hair that prevents administration of the investigational drug, have tattoos or birthmarks on the site of administration of the investigational drug, or have frequent sunburns on the skin.
6. Subjects with a complication or a history of drug dependence or alcohol dependence.
7. Subjects with a complication or a history of drug hypersensitivity.
8. Subjects with a complication or a history of food allergy.
9. Subjects who had an average of 20 grams or more of alcohol per day.
10. Subjects who used any drug or supplement within 2 weeks prior to hospitalization for this study.
11. Subjects who smoked within 4 weeks prior to the screening test.
12. Subjects who had food or beverages containing grapefruit (juice or pulp) within 3 days prior to hospitalization for this study.
13. 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.
14. 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.
15. 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.
16. Subjects with a positive for SARS-CoV-2 nucleic acid detection test on the day of hospitalization.
17. 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