A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants

January 22, 2025 updated by: AbbVie

A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Acpru /Id# 261162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).
  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.

For Part 2 only:

-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:

  • Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
  • Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.

Exclusion Criteria:

  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.

Additionally for Part 1, only:

  • Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
  • History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
  • History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
  • Evidence of hypertrophic scarring.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1, ABBV-141 (Intravenous [IV])
Western participants will receive a single IV dose of ABBV-141.
Drug: ABBV-141
Infusion; intravenous (IV)
Drug: ABBV-141
Injection; subcutaneous (SC)
Placebo Comparator: Part 1, Placebo for ABBV-141 (IV)
Western participants will receive a single IV dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Infusion; IV
Drug: Placebo for ABBV-141
Injection; SC
Experimental: Part 1, ABBV-141 (subcutaneous [SC])
Western participants will receive a single SC dose of ABBV-141.
Drug: ABBV-141
Infusion; intravenous (IV)
Drug: ABBV-141
Injection; subcutaneous (SC)
Placebo Comparator: Part 1, Placebo for ABBV-141 (SC)
Western participants will receive a single SC dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Infusion; IV
Drug: Placebo for ABBV-141
Injection; SC
Experimental: Part 2, ABBV-141 (IV)
Asian participants will receive a single IV dose of ABBV-141.
Drug: ABBV-141
Infusion; intravenous (IV)
Drug: ABBV-141
Injection; subcutaneous (SC)
Placebo Comparator: Part 2, Placebo for ABBV-141 (IV)
Asian participants will receive a single IV dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Infusion; IV
Drug: Placebo for ABBV-141
Injection; SC
Experimental: Part 2, ABBV-141 (SC)
Asian participants will receive a single SC dose of ABBV-141.
Drug: ABBV-141
Infusion; intravenous (IV)
Drug: ABBV-141
Injection; subcutaneous (SC)
Placebo Comparator: Part 2, Placebo for ABBV-141 (SC)
Asian participants will receive a single SC dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Infusion; IV
Drug: Placebo for ABBV-141
Injection; SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABBV-141
Time Frame: Up to Day 85
Cmax of ABBV-141 will be assessed.
Up to Day 85
Time to Cmax (Tmax) of ABBV-141
Time Frame: Up to Day 85
Tmax of ABBV-141 will be assessed.
Up to Day 85
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
Time Frame: Up to Day 85
AUCt of ABBV-141 will be determined.
Up to Day 85
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
Time Frame: Up to Day 85
AUCinf of ABBV-141 will be assessed.
Up to Day 85
Terminal Phase Elimination Rate Constant (β) of ABBV-141
Time Frame: Up to Day 85
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Up to Day 85
Terminal Phase Elimination Half-life (t1/2) of ABBV-141
Time Frame: Up to Day 85
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Up to Day 85
Dose Normalized Cmax of ABBV-141
Time Frame: Up to Day 85
Dose normalized Cmax of ABBV-141 will be assessed.
Up to Day 85
Dose Normalized AUC of ABBV-141
Time Frame: Up to Day 85
Dose normalized AUC of ABBV-141 will be assessed.
Up to Day 85
Number of Adverse Events (AEs)
Time Frame: Baseline to Day 85
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Baseline to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M24-693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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