A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.

Inclusion Criteria19

• Individuals between 18 and 60 years of age inclusive at the time of Screening.
• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Females, Non-Childbearing Potential are eligible as defined by meeting the following criteria:
• Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
• Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level ≥ 30 IU/L.
• Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.
• Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:
• Must not be pregnant or breastfeeding.
• Must agree to avoid pregnancy while taking study treatment(s) and for at least 200 days after the last dose of study treatment.
• Must agree to use a contraceptive method listed below (as per local regulations) that is highly effective (with a failure rate of < 1% per year, when used consistently and correctly). Participants must provide documentation to the site.
• Bilateral tubal occlusion/ligation.
• Intrauterine device (IUD) to be inserted at least 30 days prior to Screening.
• Intrauterine hormone-releasing system (IUS) to be inserted at least 30 days prior to Screening.
• Part 2 only:
• Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.
• \- Han Chinese participants must be first- or second-generation Han Chinese of full Chinese parentage. First-generation participants are defined as those born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants are defined as those born outside of China to two parents and four grandparents born in China of full Chinese descent.
• OR
• \- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.