Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi \>18 and \<34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi \>18 and \<34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) * healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) * non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. * women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: 1. simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; 2. simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; 3. simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; 4. sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); 5. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. * wocbp must have a negative urine pregnancy test prior to receiving each dose. * male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. * male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. * must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. * capable of, and have given, written informed consent.

inclusion criteria: * healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi \>18 and \<34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi \>18 and \<34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) * healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) * non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. * women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: 1. simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; 2. simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; 3. simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; 4. sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); 5. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. * wocbp must have a negative urine pregnancy test prior to receiving each dose. * male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. * male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. * must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. * capable of, and have given, written informed consent.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) healthy as defined by: the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. wocbp must have a negative urine pregnancy test prior to receiving each dose. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. capable of, and have given, written informed consent.

inclusion criteria: healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) healthy as defined by: the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. wocbp must have a negative urine pregnancy test prior to receiving each dose. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. capable of, and have given, written informed consent.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) - healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) - non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. - women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: 1. simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; 2. simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; 3. simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; 4. sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); 5. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. - wocbp must have a negative urine pregnancy test prior to receiving each dose. - male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. - male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. - must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. - capable of, and have given, written informed consent.

inclusion criteria: - healthy male or non-pregnant female, ≥18 and ≤55 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 1); healthy male or non-pregnant female, ≥56 years of age, with bmi >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females (part 2) - healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (part 1); b. the absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (part 2) - non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. - women of childbearing potential (wocbp) or men whose sexual partners are wocbp must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. a female subject is considered to be a wocbp following menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include: 1. simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; 2. simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner; 3. simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration; 4. sterile male partner (vasectomized since at least 6 months prior to first study treatment administration); 5. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. - wocbp must have a negative urine pregnancy test prior to receiving each dose. - male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration. - male subjects must be willing not to donate sperm until 90 days following the last study treatment administration. - must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule. - capable of, and have given, written informed consent.