About Clinical Research
Study #55623

• Participants who are assigned female at birth and are of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined below:
o Postmenopausal: No menses for 12 months without an alternative medical cause
o Documented hysterectomy
o Documented bilateral salpingectomy
o Documented bilateral oophorectomy
o For individuals with permanent infertility due to an alternate medical cause other than the above.
o Participants on hormone replacement therapy (HRT) whose menopausal status is in doubt must discontinue HRT to allow
confirmation of postmenopausal status before study enrollment.

• Females of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria from at least 28 days before the dose of study intervention, during the intervention period and 90 days after the last dose:
o Implantable progestogen-only hormone contraception associated with inhibition of ovulation
o IUD
o Intrauterine hormone-releasing system
o Bilateral tubal occlusion
o Vasectomized Partner
o Combined (estrogen and progestogen containing) hormonal contraception
 Oral
 Intravaginal
 Transdermal
 Injectable
o Progestogen only hormone contraception
 Oral
 Injectable
o Abstinence

• Screening and dose will be on the same day Could take up to 4 hours