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A phase I study of SK-0348 in healthy adult subjects (Single dose)

Single dose study of SK-0348

46

Healthy Japanese male adults (20 years or older but under 40 years of age)

Step P (single transdermal administration): 10 subjects Discontinuation: 0 Step 1 to 3 (single transdermal administration with dose-escalation): SK-0348 group: 27 subjects (9 in each Step) Placebo group: 9 subjects (3 in each Step) Discontinuation: 2 subjects (one each in Step 2 and Step 3)

One adverse event was observed in one out of 10 subjects in Step P. In Step 1 to 3, no adverse events were observed in the placebo group while 4 events were observed in one out of 9 subjects in the SK-0348 medium-dose group and one event in one out of 9 subjects in the SK-0348 high-dose group. The event observed in the high-dose group was judged to be causally related to the study drug (The incidence of adverse drug reaction was 11.1%).

As for safety, no deaths, other serious adverse events, or other significant adverse events were observed. No clinically significant changes were found in laboratory values except for one adverse drug reaction of "increase in amylase" observed in one subject in the SK-0348 high-dose group. In addition, no clinically significant findings or changes were observed in vital signs, resting 12-lead electrocardiogram and skin irritation assessment. As for pharmacokinetic evaluation, plasma concentrations of SK-0348 were below the lower limit of quantification at all the measuring time points in the SK-0348 low and medium-dose groups when SK-0348 was put on Site A and in the SK-0348 low-dose group when SK-0348 was put on Site B. When SK-0348 was put on Site B, a tendency of dose-dependent increase was observed while the linearity for Cmax and AUC could not be evaluated. As for pharmacodynamic evaluation, a regression analysis of plasma concentrations of SK-0348 and AUC showed that the correlation could not be evaluated due to the limited number of subjects whose quantitative value of plasmas SK-0348 concentration was obtained and the low plasma concentrations of SK-0348 observed in the study.

SK-0348 had no safety concerns, while dose-response relationship could not be determined in pharmacokinetic and pharmacodynamic evaluations since the low plasma concentrations of SK-0348 were observed.

Nov. 15, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071220001

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

April. 11, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

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.

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.

Male

Healthy adult subjects

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

Safety, pharmacokinetics, and pharmacodynamics

+81-92-283-7701

April. 08, 2022

none