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

• Sponsor: AbbVie (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05686980
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 2.8
• Patients Per Site: 9
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ABBV-552	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects
• Anticipated Study Start Date: Jan 17, 2023
• Anticipated Primary Completion Date: Apr 13, 2023
• Anticipated Study Completion Date: Apr 13, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AE) [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 [Up to approximately 21 days]

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

3. Time to Cmax (Tmax) of ABBV-552 [Up to approximately 21 days]

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

4. Terminal Phase Elimination Rate Constant (λz) of ABBV-552 [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 [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 [Up to approximately 21 days]

   AUCt of ABBV-552.

7. AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552 [Up to approximately 21 days]

   AUCinf of ABBV-552.

8. Apparent Oral Clearance (CL/F) of ABBV-552 [Up to approximately 21 days]

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

9. Apparent Volume of Distribution (Vz/F) of ABBV-552 [Up to approximately 21 days]

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

10. Dose-Normalized Cmax of ABBV-552 (Arm 1) [Up to approximately 21 days]

    Dose-normalized Cmax of ABBV-552.

11. AUC of ABBV-552 (Arm 1) [Up to approximately 21 days]

    AUC of ABBV-552.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials LLC /ID# 252203	Anaheim	California	United States	92801-2658
2	PPD Clinical Research Unit -Las Vegas /ID# 252241	Las Vegas	Nevada	United States	89113-2235

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05686980
• Other Study ID Numbers: M23-512
• First Posted: Jan 17, 2023
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by AbbVie: ABBV-552; Alzheimer's disease (AD)

Study Results

No Results Posted as of Jan 17, 2023