Clinical trial 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
Official title: An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ABBV-552
Alzheimer's disease (AD)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: Up to approximately 45 days
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Time to Cmax (Tmax) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Terminal Phase Elimination Rate Constant (λz) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552
timeFrame: Up to approximately 21 days
measure: AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Apparent Oral Clearance (CL/F) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Apparent Volume of Distribution (Vz/F) of ABBV-552
timeFrame: Up to approximately 21 days
measure: Dose-Normalized Cmax of ABBV-552 (Arm 1)
timeFrame: Up to approximately 21 days
measure: AUC of ABBV-552 (Arm 1)
timeFrame: Up to approximately 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 252203
state: California
city: Las Vegas
country: United States
facility: PPD Clinical Research Unit -Las Vegas /ID# 252241
state: Nevada
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: