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ABBV-142 Safety and Tolerability in Healthy Adults

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What is being tested

ABBV-142

+ ABBV-142
+ Placebo
Drug
Who is being recruted

Healthy Volunteer

From 18 to 55 Years
+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: January 2025

See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: July 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 22, 2025Actual date on which the first participant was enrolled.

This study focuses on understanding how a new drug, ABBV-142, behaves in the body and how the body reacts to it. The goal is to see if the drug can be safely given to humans at doses that might be effective. This research targets healthy adult participants, including a specific group of healthy adult Asian subjects. Conducting this study is important as it helps determine if ABBV-142 can be used safely in future treatments, potentially leading to new, effective therapies for health conditions. Participants in this study will receive single doses of ABBV-142, with the amount gradually increasing to observe the body's response. The drug is given to participants, and researchers closely monitor its safety and how well people tolerate it. The study also examines how the drug moves through the body and whether it triggers any immune response. By carefully measuring these factors, researchers aim to ensure that the drug can be used safely in larger, more advanced trials.

Official TitleA Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects 
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: July 3, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
74 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Volunteer
Criteria
11 inclusion criteria required to participate
ll Parts
Volunteers in general good health
art 3, ONLY
AN CHINESE Participants

Show More Criteria

3 exclusion criteria prevent from participating
History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug
Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug
History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
9 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will receive ABBV-142 Dose A or Placebo on Day 1.
Group II
Experimental
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
Group III
Experimental
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
Group IV
Experimental
Participants will receive ABBV-142 Dose D or Placebo on Day 1.
Group 5
Experimental
Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.
Group 6
Experimental
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
Group 7
Experimental
Participants will receive ABBV-142 Dose C or Placebo on Day 1.
Group 8
Experimental
Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Group 9
Experimental
Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.
Study Objectives
Primary Objectives

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Cmax of ABBV-142 will be assessed.

Tmax of ABBV-142 will be assessed.

AUCt of ABBV-142 will be determined.

AUCinf of ABBV-142 will be assessed.

Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.

Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.

Dose normalized Cmax of ABBV-142 will be assessed.

Dose normalized AUC of ABBV-142 will be assessed.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Acpru /Id# 271899Grayslake, United StatesSee the location
Recruiting
One Study Center