臨床研究等提出・公開システム

SK-5307 Phase I (single-dose study in healthy adult male subjects)

SK-5307 P I single-dose study.

38

Healthy Japanese adult males: 32 subjects ( 8 subjects in each of the 4 groups ) Age: 25.8-30.0 years Body weight: 60.29-64.07 kg BMI: 20.37-21.38 kg/m2 {Mean (min. to max.) in each treatment group } Healthy Caucasian adult males: 6 subjects Age: 31.7 years Body weight: 69.70 kg BMI: 22.93 kg/m2 (mean)

Number of participants: Subjects who underwent the screening test: 131 Subjects deemed eligible for the study inclusion: 55 Step 1 to 4 (Single oral administration with dose-escalation / Healthy Japanese adult male subjects): SK-5307 group: 24 subjects (6 in each Step) Placebo group: 8 subjects (2 in each Step) Step 5 (Healthy Caucasian adult male subjects): SK-5307 group: 6 subjects Discontinuation or drop-out in all Steps: 0 (all 38 subjects were completed the study.)

No adverse events were observed in the placebo group. In the SK-5307 group, 13 events were reported in 11 of 30 subjects. Of these, 12 events in 11 subjects were judged to be related to the investigational drug.

Safety: No deaths, serious adverse events, or significant adverse events were observed. In addition, there were no clinically significant findings or changes in vital signs or resting 12-lead EGC. Pharmacokinetics: Plasma SK-5307 concentrations increased in a dose-dependent manner in the Japanese treatment group.

There were no safety concerns with SK-5307. As for pharmacokinetics, the plasma concentration of SK-5307 in the Japanese subjects showed a dose-dependent trend, and the expected profile was achieved.

Dec. 15, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071220045

Kenji Asano

Sanwa Kagaku Kenkyusho Co.,Ltd.

35, Higashi Sotobori-cho, Higashi-ku, Nagoya City, Aichi Prefecture

clinicaltrials@ml.skk-net.com

Kenji Asano

Sanwa Kagaku Kenkyusho Co.,Ltd.

35, Higashi Sotobori-cho, Higashi-ku, Nagoya City, Aichi Prefecture

+81-52-951-8130

clinicaltrials@ml.skk-net.com

Complete

Aug. 29, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

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.

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.

Male

Healthy adult subjects

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

Safety, Pharmacokinetics

+81-92-283-7701

Aug. 26, 2022

none