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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-552

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801-2658
      • Anaheim Clinical Trials LLC /ID# 252203
  • Nevada
    • Las Vegas, Nevada, United States, 89113-2235
      • PPD Clinical Research Unit -Las Vegas /ID# 252241

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's disease (AD); ABBV-552
• Other Study ID Numbers: M23-512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes