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Phase 1 Study of ABBV-243 in Healthy Adults

This study is testing a new drug called ABBV-243, given either into a vein (intravenous or IV) or under the skin (subcutaneous or SC), and comparing it to a placebo (an inactive substance). The main goal is to see if ABBV-243 is safe and how the body processes it in healthy adults. Researchers will also look at how well people tolerate the drug. You may be able to join if you are a healthy adult between 18 and 60 years old with a specific body mass index (BMI). The study will measure side effects and how much of the drug is in your blood over time to understand its safety and how it works in the body. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 66 healthy adult participants. Participants will receive either ABBV-243 or a placebo through IV infusion or SC injection.
What's involved
Participants will attend regular visits at a hospital or clinic. These visits will include medical assessments, blood tests, checking for side effects, and completing questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 204 days after receiving the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07306754

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

Recruiting
PHASE1Ages 18–60InterventionalBasic science
AbbVie
~66 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:ABBV-243Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AEs)
Measured over Up to Day 204
+7 more outcomes measured

Conditions

Healthy Volunteers

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Healthy Volunteers

NCT07306754

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Acpru /Id# 279789

    Grayslake, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Number of Participants with Adverse Events (AEs)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.

  • Maximum Observed Serum Concentration (Cmax) of ABBV-243Up to Day 204

    Maximum observed serum concentration (Cmax) of ABBV-243

  • Time to Cmax (Tmax) of ABBV-243Up to Day 204

    Time to Cmax (Tmax) of ABBV-243

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

  • Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243Up to Day 204

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

  • Terminal Phase Elimination Rate Constant (β) of ABBV-243Up to Day 204

    Terminal phase elimination rate constant of ABBV-243

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-243Up to Day 204

    Terminal phase elimination half-life of ABBV-243

  • Anti-Drug Antibody (ADA) of ABBV-243Up to Day 204

    Confirmed Positive ADA Results.