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

Study Overview
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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.

Official Title
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A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154

Conditions
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ABBV-154

Intervention / Treatment
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* Drug: ABBV-154 Dose Formulation A
* Drug: ABBV-154 Dose Formulation B


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-154 Dose A<br>Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A. | Drug: ABBV-154 Dose Formulation A<br>* Subcutaneous Injection<br>|
| Experimental: ABBV-154 Dose B<br>Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B. | Drug: ABBV-154 Dose Formulation B<br>* Subcutaneous Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | Approximately up to 58 days | 
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 58 days | 
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 58 days | 
| The Terminal Phase Elimination Half-Life (t1/2) | The Terminal Phase Elimination Half-Life (t1/2) | Approximately up to 58 days | 
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Approximately up to 58 days | 
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | Approximately up to 58 days | 
| Number of Participants with Adverse Events | 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. The investigator assesses the relationship of each event to the use of study. | Approximately up to 72 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-154