Phase
Condition
Healthy Volunteers
Treatment
Placebo
ABBV-243
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 inmeters.
Females, Non-Childbearing Potential are eligible as defined by meeting the followingcriteria:
Permanent sterility due to a hysterectomy, bilateral salpingectomy, orbilateral oophorectomy.
Non-surgical permanent infertility due to Mullerian agenesis, androgeninsensitivity, or gonadal dysgenesis; investigator discretion should be appliedto determining study entry.
Postmenopausal female who is age ≤ 55 years with no menses for 12 or moremonths 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 moremonths without an alternative medical cause.
Females, Childbearing Potential are defined as all other females who do not meet theabove 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 localregulations) that is highly effective (with a failure rate of < 1% per year,when used consistently and correctly). Participants must provide documentationto 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 daysprior 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.
Exclusion
Exclusion Criteria:
History: of epilepsy, any clinically significant cardiovascular, respiratory (exceptmild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic orpsychiatric disease or disorder, or any uncontrolled medical illness.
History of any clinically significant sensitivity or allergy to any medication orfood.
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia)other than successfully treated non-metastatic cutaneous squamous cell, basal cellcarcinoma, or localized carcinoma in situ of the cervix.
History or evidence of active Tuberculosis (TB) disease or latent TB infection.
Study Design
Connect with a study center
Acpru /Id# 279789
Grayslake 4894465, Illinois 4896861 60030
United StatesActive - Recruiting

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