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New drug ABBV-243 put to the test in healthy volunteers

NCT ID NCT07306754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study is testing a new drug called ABBV-243 in healthy adults to see if it is safe and how the body processes it. About 66 participants will receive either the drug or a placebo, given as an injection or IV. The study does not aim to treat any disease, but to gather important safety information before testing in patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Acpru /Id# 279789

    RECRUITING

    Grayslake, Illinois, 60030, United States

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