Oral ABBV-1042 tolerability and how the body handles it in healthy adults

A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects

This will test how different oral doses of ABBV-1042 are tolerated and how the drug moves through the bodies of healthy adult volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 1 site (Grayslake, Illinois)
• Trial ID: NCT07222709 on ClinicalTrials.gov

What this trial studies

This is a phase 1, randomized, placebo-controlled, single-ascending-dose design in healthy adult volunteers to characterize adverse events, tolerability, and pharmacokinetics of oral ABBV-1042. Participants who meet inclusion criteria (BMI 18.0–32.0 kg/m2, weight >45 kg, and generally healthy) will receive ascending oral doses of ABBV-1042 or placebo under confinement with safety monitoring and serial blood sampling for pharmacokinetic analysis. Key exclusions include recent suicidal ideation or behavior and significant cardiovascular, pulmonary, hepatic, renal, metabolic, endocrine, or other major medical conditions. The trial is sponsored by AbbVie and conducted at a single clinical research site in Grayslake, Illinois.

Who should consider this trial

Good fit: Ideal candidates are healthy adults who meet the BMI and weight requirements, have no significant medical or psychiatric history, and can attend in-person confinement at the study site.

Not a fit: People with active medical conditions, significant organ disease, recent suicidal thoughts or behaviors, or those outside the BMI/weight ranges are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the trial could define safe dose ranges and pharmacokinetic profiles that guide later patient trials.

How similar studies have performed: Phase 1 single-ascending-dose pharmacokinetic and tolerability trials are a standard early step that have supported development of many therapies, but ABBV-1042 itself has no published efficacy data yet.

Eligibility criteria

Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32.0 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.
* Body weight ˃ 45 kg at the time of screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

* History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
* Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.

Where this trial is running

Grayslake, Illinois

• Acpru /Id# 279405 — Grayslake, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Healthy Volunteer; ABBV-1042