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

NCT07736638 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-924
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Adverse Events (AEs)

  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.

  Up to 99 Days

• Maximum Observed Serum Concentration (Cmax) of ABBV-859

  Cmax of ABBV-859

  Up to 99 Days

• Time to Cmax (Tmax) of ABBV-859

  Time to Cmax (Tmax) of ABBV-859

  Up to 99 Days

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

  Beta of ABBV-859

  Up to 99 Days

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

  t1/2 of ABBV-859

  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

  AUCt of ABBV-859

  Up to 99 Days

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

  AUCinf of ABBV-859

  Up to 99 Days

• Apparent Clearance (CL/F) ABBV-859

  CL/F of ABBV-859

  Up to 99 Days

• Antidrug Antibody (ADA)

  Incidence and concentration of anti-drug antibodies.

  Up to 99 Days

Study Arms (8)

Group 1

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 2

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 3

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 4

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 5

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 6

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 7

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Group 8

EXPERIMENTAL

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

Drug: ABBV-859; Drug: Placebo for ABBV-859

Interventions

ABBV-859 DRUG

Oral Tablet

Group 5; Group 6; Group 7; Group 8

Placebo for ABBV-859 DRUG

Oral Tablet

Group 5; Group 6; Group 7; Group 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share