Healty participants
Conditions
Interventions
Treatment arm : LYS006
Placebo arm : Placebo
Sponsors
Yamada Hiroyuki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed