A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants

Study Overview
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Brief Summary
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This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will be assessed. ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be enrolled in 2 sites in the United States. Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their last dose. Participants will be confined for 22 days or 8 days depending on the Arm they are assigned to. Adverse Events and blood tests will be performed.

Official Title
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An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ABBV-552


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet. OR Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. Exclusion Criteria: - Has no other clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive ABBV-552.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Healthy Japanese Participants<br>Participants will receive ABBV-552 once a week for 21 Days. | Drug: ABBV-552<br>* Oral Capsule<br>|
| Experimental: Arm 2: Healthy Han Chinese Participants<br>Participants will receive ABBV-552 once a week for 7 Days. | Drug: ABBV-552<br>* Oral Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to approximately 45 days | 
| Maximum Observed Plasma Concentration (Cmax) of ABBV-552 | Maximum observed plasma concentration (Cmax) of ABBV-552. | Up to approximately 21 days | 
| Time to Cmax (Tmax) of ABBV-552 | The time to Cmax (Tmax) of ABBV-552. | Up to approximately 21 days | 
| Terminal Phase Elimination Rate Constant (λz) of ABBV-552 | Terminal phase elimination rate constant (λz) of ABBV-552. | Up to approximately 21 days | 
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-552 | Terminal phase elimination half-life (t1/2) of ABBV-552. | Up to approximately 21 days | 
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552 | AUCt of ABBV-552. | Up to approximately 21 days | 
| AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552 | AUCinf of ABBV-552. | Up to approximately 21 days | 
| Apparent Oral Clearance (CL/F) of ABBV-552 | Apparent oral clearance (CL/F) of ABBV-552. | Up to approximately 21 days | 
| Apparent Volume of Distribution (Vz/F) of ABBV-552 | Apparent volume of distribution (Vz/F) of ABBV-552. | Up to approximately 21 days | 
| Dose-Normalized Cmax of ABBV-552 (Arm 1) | Dose-normalized Cmax of ABBV-552. | Up to approximately 21 days | 
| AUC of ABBV-552 (Arm 1) | AUC of ABBV-552. | Up to approximately 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-552, Alzheimer's disease (AD)