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

NCT05686980 | Completed Phase 1 FDA Drug

• 1 other identifier: M23-512
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

ABBV-552; Alzheimer's disease (AD)

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Arm 1: Healthy Japanese Participants

EXPERIMENTAL

Participants will receive ABBV-552 once a week for 21 Days.

Drug: ABBV-552

Arm 2: Healthy Han Chinese Participants

EXPERIMENTAL

Participants will receive ABBV-552 once a week for 7 Days.

Drug: ABBV-552

Interventions

ABBV-552 DRUG

Oral Capsule

Arm 1: Healthy Japanese Participants; Arm 2: Healthy Han Chinese Participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Anaheim Clinical Trials LLC /ID# 252203

Anaheim, California, 92801-2658, United States

Location

PPD Clinical Research Unit -Las Vegas /ID# 252241

Las Vegas, Nevada, 89113-2235, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 17, 2023
• Study Start: January 17, 2023
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)