臨床研究等提出・公開システム

Phase I Clinical Study -Multiple Dose Study of CNT-01-

Phase I Clinical Study -Multiple Dose Study of CNT-01-

Akita Yasuhiko

TOA EIYO LTD.

2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA

ct_info@toaeiyo.co.jp

Clinical Development Dept.

TOA EIYO LTD.

2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA

+81-48-647-7975

ct_info@toaeiyo.co.jp

Complete

April. 15, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

1) Subjects who signed the written informed consent
2) Age>=20 and =<40 at time of consent
3) Weight>=45kg, height>=140 cm, and body mass index (BMI) >=18.5 and <25.0 at screening

1) Subjects with complications such as medically significant gastrointestinal, renal, respiratory, endocrine, hematological, nervous, psychiatric, cardiovascular, or congenital metabolic abnormalities.
2) Subjects with acute illness within 2 weeks prior to administration of the investigational drug.
3) Subjects with a current or past history of drug or food allergy.
4) Subjects with QTcF of 450 msec or more, PR interval of 220 msec or more, or QRS width of 120 msec or more on 12-lead ECG performed before administration on Day 1.
5) Subjects with a history of syncope.
6) Subjects with family history of congenital long QT syndrome or sudden cardiac death.
7) Patients with a history of infection requiring treatment within 4 weeks prior to administration of the investigational drug.
8) Persons with a positive SARS-CoV-2 test (nucleic acid amplification test) or suspected COVID-19 test performed within 3 days before admission to the hospital.

Male

Idiopathic triglyceride deposit cardiomyovasculopathy

Study drug: CNT-01 500 mg, 1500 mg or 4500 mg is administered orally as a single dose or three times daily for 7 days.
Control drug: CNT-01 placebo is administered orally as a single dose or three times daily for 7 days.

Pharmacokinetics, Effect on QTcF and Safety

+81-92-283-7701

April. 09, 2021

No

none