Created at Source Raw Value Validated value
Aug. 27, 2021, 9:45 p.m. oms

1) Subjects aged between >18 and <85 years at the time of informed consent2) Subjects who provided written informed consent. For underage subjects, written consent must be obtained from the subject and the subjects legally acceptable representative3) Subjects who will be available for the study schedule and able to comply with subject requirements of the study and at the study center4) Subjects who are HIV-negative at screening5) Subjects with an axillary body temperature of <37.0 digrees on the day of enrollment6) Subjects with negative real-time polymerase chain reaction (PCR) for SARS-CoV-2 in saliva at screening7) Subjects with negative serum anti-SARS-CoV-2 antibodies (IgG and IgM) at screening8) Subjects without clinically relevant abnormal findings on chest X-ray at screening9) Subjects with a body mass index (BMI) of >18.5 to <30.0 kg/m^2 at screening10) Subjects without clinically relevant abnormal findings on 12-lead electrocardiogram (ECG) at screening11) Subjects with all laboratory test values at screening being within the reference ranges for the population or laboratory, or subjects with values outside the reference ranges judged by the investigator/sub-investigator to be clinically insignificant12) Female subjects of childbearing potential, who have a negative serum or urine pregnancy test and agree to use an adequate method of contraception during the study period13)Subjects judged by the investigator/sub-investigator to be appropriate for inclusion in the study on the basis of the medical history, physical findings, and laboratory data

1) Subjects aged between >18 and <85 years at the time of informed consent2) Subjects who provided written informed consent. For underage subjects, written consent must be obtained from the subject and the subjects legally acceptable representative3) Subjects who will be available for the study schedule and able to comply with subject requirements of the study and at the study center4) Subjects who are HIV-negative at screening5) Subjects with an axillary body temperature of <37.0 digrees on the day of enrollment6) Subjects with negative real-time polymerase chain reaction (PCR) for SARS-CoV-2 in saliva at screening7) Subjects with negative serum anti-SARS-CoV-2 antibodies (IgG and IgM) at screening8) Subjects without clinically relevant abnormal findings on chest X-ray at screening9) Subjects with a body mass index (BMI) of >18.5 to <30.0 kg/m^2 at screening10) Subjects without clinically relevant abnormal findings on 12-lead electrocardiogram (ECG) at screening11) Subjects with all laboratory test values at screening being within the reference ranges for the population or laboratory, or subjects with values outside the reference ranges judged by the investigator/sub-investigator to be clinically insignificant12) Female subjects of childbearing potential, who have a negative serum or urine pregnancy test and agree to use an adequate method of contraception during the study period13)Subjects judged by the investigator/sub-investigator to be appropriate for inclusion in the study on the basis of the medical history, physical findings, and laboratory data