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A phase 1 single-dose study of S-151128 in Japanese healthy adults

Phase 1 single-dose study of S-151128

56

All participants were male. The mean age (SD) was 24.5 (9.8) to 34.8 (9.2) years in the S-151128 dose groups (7 dose levels), and 29.4 (9.5) years in the placebo group.

A total of 56 participants were randomized across all 7 cohorts, including 42 participants who received S-151128 and 14 participants who received placebo. All participants completed the study. All 56 participants (42 in the S-151128 group and 14 in the placebo group) were included in the safety analysis population.

No deaths, or serious adverse events (AEs) were reported in this study. All AEs were Grade 1 in severity except for 1 AE of Grade 3 reported in the placebo group. Adverse events that occurred in 2 or more participants in the S-151128 groups were nasopharyngitis, back pain, and blood pressure decreased. No treatment-related adverse events were reported in the S-151128 groups.

The results of adverse events are presented in the "Adverse events" section. No clinically significant abnormal findings related to S-151128 were observed in clinical laboratory tests, vital signs, 12-lead ECGs, Holter ECG, the Schellong test, hand bath test, questionnaire on the sense of smell and taste, or other safety assessments.

S-151128 was safe and well tolerated when administered intravenously as a single dose at 7 dose levels to Japanese healthy adults.

Sept. 20, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230023

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

April. 22, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Aged 18 to 55 years, inclusive, at the time of informed consent.
-Apparently healthy in the opinion of the investigator at screening and on admission.
-Having Japanese parents.

-Systolic blood pressure at rest falling outside the range of 90 to 140 mmHg or diastolic blood pressure falling outside the range of 50 to 90 mmHg, or pulse rate falling outside the range of 50 to 90 bpm at screening or admission and are considered ineligible for this study by the investigator.
-Current or a history of syncope of unknown cause, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolonged, or conduction abnormality.
-Current or a history of risk factors for Torsade de Pointes (eg, cardiac failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome).

Both

Chronic Pain

a single intravenous infusion of S-151128 or placebo

Adverse events, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (systolic/diastolic blood pressure, body temperature, pulse rate, respiratory rate, and SpO2), 12-lead ECG (HR, PR, QRS, QT, RR, QTcF), Holter ECG, Schellong test, heat perception test (warm detection threshold, heat pain threshold), hand bath test, standard pure tone audiometry, and questionnaire on sense of smell and taste

+81-3-5366-3006

April. 12, 2023

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