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A Single/Multiple Dose Study of SSJG-009 (Phase I)

A Single/Multiple Dose Study of SSJG-009 (Phase I)

9

All the participants were healthy Japanese adult males. The mean ages in the SSJG-009 and placebo groups were 28.5 and 29.7 years, respectively, and the mean BMI in both groups was 21.80 kg/m2.

9 eligible participants were enrolled at the same time and randomly assigned: 6 received SSJG-009 and 3 received a placebo. All participants were followed up and analyzed according to the study protocol until discharge.

- In this study, no deaths, serious adverse events, or adverse events leading to discontinuation of the investigational drug were observed. - AEs by PT occurred in 3 cases in the SSJG-009 group and 1 case in the placebo group; all were mild and resolved without treatment.

Pharmacokinetics: During the single-dose phase in the SSJG-009 group, Cmax was 30.55 ng/mL, tmax was 2.500 h, and AUC0-t was 107.93 ng*h/mL. Additionally, the parameters during the repeated-dose phase were similar to those in the single-dose phase, and no accumulation was noted. Safety: - In this study, no deaths, serious adverse events, or adverse events leading to discontinuation of the investigational drug were observed. - AEs by PT occurred in 3 cases in the SSJG-009 group and 1 case in the placebo group; all were mild and resolved without treatment.

It was confirmed that there were no clinical safety concerns with SSJG-009 at the dosage and administration method used in this trial.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2051240138

Fujisawa Kouichi

Sunstar Inc.

Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan

ssjg009@jp.sunstar.com

Fujisawa Kouichi

Sunstar Inc.

Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan

+81-80-9937-4055

ssjg009@jp.sunstar.com

Complete

Oct. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

other

1. Healthy Japanese adult males aged 20 to 40 years on the day of consent, who the investigator or subinvestigator considers to be in good physical health and be clinically normal based on a full-body examination, including medical history, blood pressure, and pulse rate.
2. Subjects with a BMI (body mass index) of 18.5 or more and less than 25.0
BMI (kg/m2) = weight (kg)/[height (m)]2
3. Subjects have been fully informed about the investigational drug and the outline of the clinical trial, volunteered, and given written consent to participate in the clinical trial.

(1) Subjects with a health condition that may affect the absorption, distribution, metabolism, and excretion of the investigational drug, or a history of such a condition (e.g., history of resection of the liver, kidneys, gallbladder, or digestive tract).
(2) Subjects with a serious cardiac, vascular, renal, liver, digestive, endocrine, nervous, skin, metabolic, or immune disease, or a history of such a disease.
(3) Subjects with blood abnormalities (aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia, etc.), or a history of such an abnormality.
(4) Subjects with a tendency to bleed.
(5) Subjects with hypertension.
(6) Subjects with a peptic ulcer, or a history of such an abnormality.
(7) Subjects with aspirin-induced asthma, or a history of such an abnormality.
(8) Subjects with a history of drug hypersensitivity, asthma, urticaria, or other significant allergic predisposition.
(9)Subjects with a history of hypersensitivity to any ingredient (including additives) of this product.
(10) Subjects with or a history of hypersensitivity to influenza-related encephalopathy or encephalitis.
(11) Subjects currently receiving or who may be receiving triamterene.
(12) Subjects with clinical abnormalities in 12-lead resting electrocardiograms or significant prolongation of the QT/QTc interval.
(13) Subjects with positive results for hepatitis B, hepatitis C, HIV, or syphilis.
(14) Subjects who are determined by the principal investigator (subinvestigator) to be ineligible to participate in this clinical trial in a screening test.
(15) Subjects who are otherwise determined by the principal investigator (subinvestigator) to be ineligible to participate in this clinical trial.

Male

Healthy Japanese adult males

Treatment group:SSJG-009 Placebo group:Placebo

Safety, Pharmacokinetics

+81-6-6395-9000

Sept. 20, 2024

none