Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-02-17

Brief Summary

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This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.

ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.

All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.

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Detailed Description

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Conditions

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ABBV-154

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABBV-154 Dose A

Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A.

Group Type EXPERIMENTAL

ABBV-154 Dose Formulation A

Intervention Type DRUG

Subcutaneous Injection

ABBV-154 Dose B

Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B.

Group Type EXPERIMENTAL

ABBV-154 Dose Formulation B

Intervention Type DRUG

Subcutaneous Injection

Interventions

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ABBV-154 Dose Formulation A

Subcutaneous Injection

Intervention Type DRUG

ABBV-154 Dose Formulation B

Subcutaneous Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.

Exclusion Criteria

* Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to similar biologic therapies.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes