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Completed

NCT Number: NCT05686980

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

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.

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Key information

Conditions

Healthy Volunteers Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials LLC /ID# 252203, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-552

Drug

Oral Capsule

Primary outcomes

  1. Number of Participants With Adverse Events (AE)

    Time frame: Up to approximately 45 days

    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.

  2. Maximum Observed Plasma Concentration (Cmax) of ABBV-552

    Time frame: Up to approximately 21 days

    Maximum observed plasma concentration (Cmax) of ABBV-552.

  3. Time to Cmax (Tmax) of ABBV-552

    Time frame: Up to approximately 21 days

    The time to Cmax (Tmax) of ABBV-552.

  4. Terminal Phase Elimination Rate Constant (λz) of ABBV-552

    Time frame: Up to approximately 21 days

    Terminal phase elimination rate constant (λz) of ABBV-552.

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-552

    Time frame: Up to approximately 21 days

    Terminal phase elimination half-life (t1/2) of ABBV-552.

  6. Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552

    Time frame: Up to approximately 21 days

    AUCt of ABBV-552.

  7. AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552

    Time frame: Up to approximately 21 days

    AUCinf of ABBV-552.

  8. Apparent Oral Clearance (CL/F) of ABBV-552

    Time frame: Up to approximately 21 days

    Apparent oral clearance (CL/F) of ABBV-552.

  9. Apparent Volume of Distribution (Vz/F) of ABBV-552

    Time frame: Up to approximately 21 days

    Apparent volume of distribution (Vz/F) of ABBV-552.

  10. Dose-Normalized Cmax of ABBV-552 (Arm 1)

    Time frame: Up to approximately 21 days

    Dose-normalized Cmax of ABBV-552.

  11. AUC of ABBV-552 (Arm 1)

    Time frame: Up to approximately 21 days

    AUC of ABBV-552.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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