ABBV-859: testing single-dose safety and how the medicine moves through the body in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial is designed to assess the pharmacokinetics, safety, tolerability, and immunogenicity of ABBV-859 after single ascending doses in healthy volunteers. Participants will receive ABBV-859 or placebo in a controlled setting to evaluate how the drug is absorbed, distributed, metabolized, and excreted, as well as any immune responses. The study will exclude individuals with significant medical conditions or histories that could confound results, and will require informed consent, screening assessments, and ongoing safety monitoring. Primary endpoints focus on safety and PK parameters, with immunogenicity as a secondary consideration. The trial is conducted at two U.S. sites under AbbVie sponsorship with independent oversight.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
* Body Mass Index (BMI) is \>= 18.0 to \<= 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
* 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 disease or latent Tuberculosis infection.

Where it's running

• CenExel ACT- Anaheim Clinical Trials /ID# 284382
  Anaheim, California, United States Recruiting
• Acpru /Id# 284029
  Grayslake, Illinois, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.