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NCT Number: NCT07736638

A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ABBV-859

Drug

Oral Tablet

Placebo for ABBV-859

Drug

Oral Tablet

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 99 Days

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-859

    Time frame: Up to 99 Days

    Cmax of ABBV-859

  3. Time to Cmax (Tmax) of ABBV-859

    Time frame: Up to 99 Days

    Time to Cmax (Tmax) of ABBV-859

  4. Terminal Phase Elimination Rate Constant (Beta) of ABBV-859

    Time frame: Up to 99 Days

    Beta of ABBV-859

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-859

    Time frame: Up to 99 Days

    t1/2 of ABBV-859

  6. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859

    Time frame: Up to 99 Days

    AUCt of ABBV-859

  7. AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859

    Time frame: Up to 99 Days

    AUCinf of ABBV-859

  8. Apparent Clearance (CL/F) ABBV-859

    Time frame: Up to 99 Days

    CL/F of ABBV-859

  9. Antidrug Antibody (ADA)

    Time frame: Up to 99 Days

    Incidence and concentration of anti-drug antibodies.

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 First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 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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