Recruiting
Phase 1

ABBV-859

Sponsor:

AbbVie

Code:

NCT07736638

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ABBV-859

Placebo for ABBV-859

ABBV-859

Placebo for ABBV-859

Study Details

Brief summary:

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.

Conditions

Healthy Volunteer

Study ID

NCT07736638

Start date

Jul 28, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1

experimental: Group 2

Participants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1

experimental: Group 3

Participants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1

experimental: Group 4

Participants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1

experimental: Group 5

Participants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1

experimental: Group 6

Participants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1

experimental: Group 7

Participants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1

experimental: Group 8

Participants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1

Interventions

ABBV-859

Oral Tablet

Placebo for ABBV-859

Oral Tablet

ABBV-859

Intravenous (IV) Infusion

Placebo for ABBV-859

Intravenous (IV) Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 99 Days ]
  • Maximum Observed Serum Concentration (Cmax) of ABBV-859 [ Time Frame: Up to 99 Days ]
  • Time to Cmax (Tmax) of ABBV-859 [ Time Frame: Up to 99 Days ]
  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-859 [ Time Frame: Up to 99 Days ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-859 [ Time Frame: Up to 99 Days ]
  • 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 ]
  • AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859 [ Time Frame: Up to 99 Days ]
  • Apparent Clearance (CL/F) ABBV-859 [ Time Frame: Up to 99 Days ]
  • Antidrug Antibody (ADA) [ Time Frame: Up to 99 Days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

CenExel ACT- Anaheim Clinical Trials /ID# 284382

Recruiting

Anaheim, California, United States, 92801

Acpru /Id# 284029

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Healthy Volunteer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-03.