Surgically sterile women, defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), bilateral salpingectomy, or bilateral tubal ligation.Post-menopausal women must have had ≥12 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) concentration consistently ≥40 mIU/mL and must have a negative pregnancy test result at screening and check-in.Female subjects must have a negative pregnancy test result at screening and check-in and, on admission to the unit, must not be lactating.įemale subjects must be of non-childbearing potential, as confirmed at screening by fulfilling one of the following criteria:.Individuals who weigh ≥50 kg and who have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.Individuals who are healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.Subjects must be ≥18 and less than or equal to 65 years of age at the time of signing the Informed Consent Form.Provision of signed and dated, written Informed Consent Form prior to any mandatory study specific procedures, sampling, and analyses.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this clinical study protocol.Why Should I Register and Submit Results?.
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