Healthy VolunteersPhase 1NCT05686980
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
A Phase 1 study testing ABBV-552 in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2023to 30 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials LLC /ID# 252203
Anaheim, California, 92801-2658
PPD Clinical Research Unit -Las Vegas /ID# 252241
Las Vegas, Nevada, 89113-2235
About this study
Official title: 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.
Read more
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
- Being tested
- ABBV-552
- Keywords
- ABBV-552, Alzheimer's disease (AD)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-552Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Healthy Japanese Participants | Experimental | Participants will receive ABBV-552 once a week for 21 Days. Receives: Drug: ABBV-552 |
| Arm 2: Healthy Han Chinese Participants | Experimental | Participants will receive ABBV-552 once a week for 7 Days. Receives: Drug: ABBV-552 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 45 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-552
Maximum observed plasma concentration (Cmax) of ABBV-552.
Measured: Up to approximately 21 days
Time to Cmax (Tmax) of ABBV-552
The time to Cmax (Tmax) of ABBV-552.
Measured: Up to approximately 21 days
Terminal Phase Elimination Rate Constant (λz) of ABBV-552
Terminal phase elimination rate constant (λz) of ABBV-552.
Measured: 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.
Measured: 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.
Measured: Up to approximately 21 days
AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552
AUCinf of ABBV-552.
Measured: Up to approximately 21 days
Apparent Oral Clearance (CL/F) of ABBV-552
Apparent oral clearance (CL/F) of ABBV-552.
Measured: Up to approximately 21 days
Apparent Volume of Distribution (Vz/F) of ABBV-552
Apparent volume of distribution (Vz/F) of ABBV-552.
Measured: Up to approximately 21 days
Dose-Normalized Cmax of ABBV-552 (Arm 1)
Dose-normalized Cmax of ABBV-552.
Measured: Up to approximately 21 days
AUC of ABBV-552 (Arm 1)
AUC of ABBV-552.
Measured: Up to approximately 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start17 Jan 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686980
- Sponsor's protocol ID
- M23-512
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miles N, McNamee B, Zadikoff C, Boiser J, Shebley M, Boinpally R. Comparison of ABBV-552 Safety and Pharmacokinetics in Healthy Asian and Western Adults. Clin Pharmacol Drug Dev. 2026 Jul;15(7):e70072. doi: 10.1002/cpdd.70072.
PubMed 42387856
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects
- ClinicalTrials.gov ID
- NCT05686980
- Acronym / sponsor ID
- M23-512
- Conditions
- Healthy Volunteers
- Keywords
- ABBV-552, Alzheimer's disease (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Healthy Japanese Participants | Experimental | Drug: ABBV-552Participants will receive ABBV-552 once a week for 21 Days. |
| Arm 2: Healthy Han Chinese Participants | Experimental | Drug: ABBV-552Participants will receive ABBV-552 once a week for 7 Days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-552Oral Capsule | Drug | Arm 1: Healthy Japanese Participants, Arm 2: Healthy Han Chinese Participants |
Primary outcome
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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-552
Time frame: Up to approximately 21 days
Maximum observed plasma concentration (Cmax) of ABBV-552.
Time to Cmax (Tmax) of ABBV-552
Time frame: Up to approximately 21 days
The time to Cmax (Tmax) of ABBV-552.
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.
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.
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.
AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552
Time frame: Up to approximately 21 days
AUCinf of ABBV-552.
Apparent Oral Clearance (CL/F) of ABBV-552
Time frame: Up to approximately 21 days
Apparent oral clearance (CL/F) of ABBV-552.
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.
Dose-Normalized Cmax of ABBV-552 (Arm 1)
Time frame: Up to approximately 21 days
Dose-normalized Cmax of ABBV-552.
AUC of ABBV-552 (Arm 1)
Time frame: Up to approximately 21 days
AUC of ABBV-552.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 42387856Miles N, McNamee B, Zadikoff C, Boiser J, Shebley M, Boinpally R. Comparison of ABBV-552 Safety and Pharmacokinetics in Healthy Asian and Western Adults. Clin Pharmacol Drug Dev. 2026 Jul;15(7):e70072. doi: 10.1002/cpdd.70072.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-552 in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE) (time frame: Up to approximately 45 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.