臨床研究等提出・公開システム

SK-1887 Phase I study (single-dose study in healthy adult male subjects)

SK-1887 P I (single-dose study)

Kazuo Kuyama

Sanwa Kagaku Kenkyusho Co.,Ltd.

Heiwa Fudosan Sakuradori Bldg. (Reception 6F) , 1-3-7, Nishiki, Naka-ku, Nagoya City, Aichi Prefecture

clinicaltrials@ml.skk-net.com

Kazuo Kuyama

Sanwa Kagaku Kenkyusho Co.,Ltd.

Heiwa Fudosan Sakuradori Bldg. (Reception 6F) , 1-3-7, Nishiki, Naka-ku, Nagoya City, Aichi Prefecture

+81-52-951-8130

clinicaltrials@ml.skk-net.com

Complete

Mar. 24, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

1. Subjects aged 18 years or older but less than 40 years (at the time of informed consent)
2. Subjects with a body weight of 50 kg or more but less than 80 kg (at the time of screening)
3. Subjects with BMI (weight (kg)/[height (m)]2) of 18.5 to less than 25.0 (at the time of screening)
4. Subjects with SBP of under 120 mmHg and DBP of under 80 mmHg (at the time of screening)
5. Subjects who have the capacity to consent and provide written consent.

1. Subjects with current medical history.
2. Subjects with a past medical history of endocrine, neoplastic, ocular, urologic, hepatic, renal, cardiovascular, hematologic, gastrointestinal, respiratory, psychiatric/cranial nerve, or infectious disease that the investigator or sub-investigator considers to affect the safety of the subject and the evaluation of the investigational drug
3. Subjects with a pulse rate of less than 50 beats/minute at the time of screening test
4. Subjects with clinically significant abnormalities in the resting 12-lead electrocardiogram of the screening test
5. Subjects with current or previous drug depencence, alcohol dependence, hypersensitivity or/and food allergy.
6. Subjects who consume an average of 20 g or more of alcohol per day.
7. Subjects who smoked within 28 days prior to admission
8. Subjects who used any drugs or supplements within 14 days prior to admission.
9. Subjects who are considered by the investigator or subinvestigator to be inappropriate to participate in the study.

Male

Healthy adult subjects

Single oral dose of SK-1887 or placebo with dose escalation

Safety, pharmacokinetics, pharmacodynamics , dietary effects

+81-92-283-7701

Mar. 21, 2025

No

none