Safety and how the body handles ABBV-243 in healthy adults

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

This test checks whether ABBV-243 is safe and how the body processes it when given as a single IV or under-the-skin dose to healthy adults, including a small group of Asian volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 1 site (Grayslake, Illinois)
• Trial ID: NCT07306754 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, placebo-controlled, single-ascending-dose study gives healthy adult volunteers single intravenous (IV) or single subcutaneous (SC) doses of ABBV-243 (Part 1) and a single IV dose in healthy Asian adults (Part 2) to characterize safety, tolerability, pharmacokinetics, and immunogenicity. Participants are enrolled in escalating dose cohorts with some receiving placebo and will attend scheduled clinic visits for medical assessments, blood draws, and questionnaires. The protocol collects time‑course blood samples to measure drug levels, monitors for immune responses against the drug, and records any adverse events. Results will be used to define safe dose ranges and inform dosing and route choices for later patient trials.

Who should consider this trial

Good fit: Healthy adults aged 18–60 years with a BMI of 18.0–32.0 kg/m2 who meet the study's reproductive-status requirements and have no significant medical conditions are the intended participants.

Not a fit: People with active medical problems, pregnant or breastfeeding women, those outside the 18–60 age range, or those unable to attend frequent clinic visits are unlikely to benefit from participating.

Why it matters

Potential benefit: If findings show acceptable safety and predictable pharmacokinetics, the study could define safe dose ranges and routes to support further testing in patients.

How similar studies have performed: Single-ascending-dose Phase 1 designs are a standard first-in-human approach and several similar biologic agents have advanced after acceptable safety and PK results, although ABBV-243 itself is a novel investigational molecule.

Eligibility criteria

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.

Where this trial is running

Grayslake, Illinois

• Acpru /Id# 279789 — Grayslake, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Healthy Volunteers