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NCT Number: NCT07306754

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

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.

Recruiting

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 279789

Grayslake, Illinois, 60030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

  • History: of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma, or localized carcinoma in situ of the cervix.
  • History or evidence of active Tuberculosis (TB) disease or latent TB infection.

Treatment and study plan

ABBV-243

Drug

Intravenous (IV) Infusion

Placebo

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 204

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-243

    Time frame: Up to Day 204

    Maximum observed serum concentration (Cmax) of ABBV-243

  3. Time to Cmax (Tmax) of ABBV-243

    Time frame: Up to Day 204

    Time to Cmax (Tmax) of ABBV-243

  4. Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243

    Time frame: Up to Day 204

    Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243

  5. Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243

    Time frame: Up to Day 204

    AUC from time 0 to infinite time (AUCinf) of ABBV-243

  6. Terminal Phase Elimination Rate Constant (β) of ABBV-243

    Time frame: Up to Day 204

    Terminal phase elimination rate constant of ABBV-243

  7. Terminal Phase Elimination Half-Life (t1/2) of ABBV-243

    Time frame: Up to Day 204

    Terminal phase elimination half-life of ABBV-243

  8. Anti-Drug Antibody (ADA) of ABBV-243

    Time frame: Up to Day 204

    Confirmed Positive ADA Results.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses (SAD) of ABBV-243 in Healthy Adult Subjects and a Single Dose in Healthy Asian Adult Subjects

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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