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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ABBV-141
* Drug: Placebo for ABBV-141
* Drug: ABBV-141
* Drug: Placebo for ABBV-141


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, ABBV-141 (Intravenous [IV])<br>Western participants will receive a single IV dose of ABBV-141. | Drug: ABBV-141<br>* Infusion; intravenous (IV)<br>|
| Placebo Comparator: Part 1, Placebo for ABBV-141 (IV)<br>Western participants will receive a single IV dose of placebo for ABBV-141. | Drug: Placebo for ABBV-141<br>* Infusion; IV<br>|
| Experimental: Part 1, ABBV-141 (subcutaneous [SC])<br>Western participants will receive a single SC dose of ABBV-141. | Drug: ABBV-141<br>* Injection; subcutaneous (SC)<br>|
| Placebo Comparator: Part 1, Placebo for ABBV-141 (SC)<br>Western participants will receive a single SC dose of placebo for ABBV-141. | Drug: Placebo for ABBV-141<br>* Injection; SC<br>|
| Experimental: Part 2, ABBV-141 (IV)<br>Asian participants will receive a single IV dose of ABBV-141. | Drug: ABBV-141<br>* Infusion; intravenous (IV)<br>|
| Placebo Comparator: Part 2, Placebo for ABBV-141 (IV)<br>Asian participants will receive a single IV dose of placebo for ABBV-141. | Drug: Placebo for ABBV-141<br>* Infusion; IV<br>|
| Experimental: Part 2, ABBV-141 (SC)<br>Asian participants will receive a single SC dose of ABBV-141. | Drug: ABBV-141<br>* Injection; subcutaneous (SC)<br>|
| Placebo Comparator: Part 2, Placebo for ABBV-141 (SC)<br>Asian participants will receive a single SC dose of placebo for ABBV-141. | Drug: Placebo for ABBV-141<br>* Injection; SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-141 | Cmax of ABBV-141 will be assessed. | Up to Day 85 | 
| Time to Cmax (Tmax) of ABBV-141 | 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) | AUCt of ABBV-141 will be determined. | Up to Day 85 | 
| AUC of ABBV-141 from Time 0 to Infinity (AUCinf) | AUCinf of ABBV-141 will be assessed. | Up to Day 85 | 
| Terminal Phase Elimination Rate Constant (β) of ABBV-141 | 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 | Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed. | Up to Day 85 | 
| Dose Normalized Cmax of ABBV-141 | Dose normalized Cmax of ABBV-141 will be assessed. | Up to Day 85 | 
| Dose Normalized AUC of ABBV-141 | Dose normalized AUC of ABBV-141 will be assessed. | Up to Day 85 | 
| Number of Adverse Events (AEs) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-141, Healthy Volunteers