Caucasian | Gender | Age
Item
caucasian males aged 18 to 55 years at screening.
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Procedures | Healthy Tests
Item
healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at screening and day -1.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C0392366 (UMLS CUI [4,2])
Body Weight | Body mass index
Item
a body weight of ≥60 kilograms (kg) and bmi ranging from 18 to 30 kg/m2 at screening or day -1.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Adverse reactions Severe Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparations | Adverse reactions Severe Pharmaceutical Preparations Excipient | Hypersensitivity Pharmaceutical Preparations Excipient
Item
presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
boolean
C0559546 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0015237 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs
Item
participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any imp within 12 weeks or five half-lives of the imp before the administration of the imp in this clinical study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Medical History Abnormal Interferes with Clinical trial protocol | ABNORMAL PHYSICAL FINDING Interferes with Clinical trial protocol | Laboratory test result abnormal Interferes with Clinical trial protocol | Medical History Abnormal Interferes with Patient safety | ABNORMAL PHYSICAL FINDING Interferes with Patient safety | Laboratory test result abnormal Interferes with Patient safety
Item
clinically relevant abnormal medical history, physical findings, or laboratory values at screening or day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the investigator.
boolean
C0262926 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2599718 (UMLS CUI [1,4])
C0149610 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2599718 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2599718 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0149610 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
Tuberculosis | Herpes Labialis Recurrent | Pharyngitis Recurrent | Urinary tract infection Recurrent | Diarrhea Recurrent | Dysentery Recurrent | Lower respiratory tract infection Recurrent | Mycoses Recurrent
Item
previous medical history of tuberculosis or in the opinion of the investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
boolean
C0041296 (UMLS CUI [1])
C0019345 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0031350 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0042029 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0011991 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0013369 (UMLS CUI [6,1])
C2945760 (UMLS CUI [6,2])
C0149725 (UMLS CUI [7,1])
C2945760 (UMLS CUI [7,2])
C0026946 (UMLS CUI [8,1])
C2945760 (UMLS CUI [8,2])
Pharmaceutical Preparations Systemic | Topical agents | Slow release drug Active
Item
subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the imp(day 1) unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety. slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety.
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1710439 (UMLS CUI [2])
C0011202 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])