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

Last updated: January 8, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

ABBV-243

Clinical Study ID

NCT07306754
M25-776
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 17, 2025
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Acpru /Id# 279789

    Grayslake 4894465, Illinois 4896861 60030
    United States

    Active - Recruiting

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