Study of safety, tolerability and pharmacokinetics LYS006 in Japanese healthy male participants

JRCT ID: jRCT2051200111

Registered date:15/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healty participants
• Date of first enrollment: 30/01/2021
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Treatment arm : LYS006
Placebo arm : Placebo

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

- Written informed consent must be obtained before any assessment is performed.
- Healthy Japanese male participants 20 to 45 years of age included, and in good health at screening.
- Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 30 kg/m2.
- At screening andbaseline, sitting vital signs should be within the following ranges:
- body temperature between 35.0-37.5 degree
- systolic blood pressure, 90-139 mmHg
- diastolic blood pressure, 50-89 mmHg
- pulse rate, 40-90 bpm
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclude criteria

- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Use of any prescription drugs, herbal supplements, prescribed medicinal use of cannabis/marijuana, within four weeks prior to initial dosing, and/or over-the-counter medication, dietary supplements (vitamins included) within two weeks prior to initial dosing.
- History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- Hemoglobin levels below 12.0 g/dL at screening.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening :
- PR > 200 msec
- QRS complex > 120 msec
- QTcF > 450 msec

Related Information

• Primary Sponsor: Yamada Hiroyuki