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

JRCT ID: jRCT2051240138

Registered date:27/09/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese adult males
• Date of first enrollment: 01/10/2024
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Treatment group:SSJG-009 Placebo group:Placebo

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Fujisawa Kouichi