Healthy VolunteerPhase 1NCT06673238
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
A Phase 1 study testing ABBV-722 in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2024to 25 Jun 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboratory values meet the criteria specified in the protocol.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
- Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.
- Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
- Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
Show all 9Show fewer
- Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
- Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.
Who cannot join
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
- Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altasciences Clinical Los Angeles /ID# 280183
Cypress, California, 90630
Acpru /Id# 270279
Grayslake, Illinois, 60030
About this study
Official title: A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-722, Placebo
- Keywords
- Healthy Volunteer, ABBV-722
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-722Drug
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive a single dose of either ABBV-722 Dose A or placebo. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 1: Group 2 | Experimental | Participants will receive a single dose of either ABBV-722 Dose B or placebo. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 1: Group 3 | Experimental | Participants will receive a single dose of either ABBV-722 Dose C or placebo. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 1: Group 4 | Experimental | Participants will receive a single dose of either ABBV-722 Dose TBD or placebo. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 1: Group 5 | Experimental | Participants will receive a single dose of either ABBV-722 Dose TBD or placebo. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 2: Group 6 | Experimental | Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D. Receives: Drug: ABBV-722 |
| Part 2: Group 7 | Experimental | Participants who are Japanese will receive a single dose of ABBV-722 Dose D. Receives: Drug: ABBV-722 |
| Part 3: Group 8 | Experimental | Participants will receive either ABBV-722 Dose E or placebo for 14 days. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 3: Group 9 | Experimental | Participants will receive either ABBV-722 Dose F or placebo for 14 days. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 3: Group 10 | Experimental | Participants will receive either ABBV-722 Dose A or placebo for 14 days. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 3: Group 11 | Experimental | Participants will receive either ABBV-722 Dose G or placebo for 14 days. Receives: Drug: ABBV-722; Drug: Placebo |
| Part 3: Group 12 | Experimental | Participants will receive either ABBV-722 Dose TBD or placebo for 14 days. Receives: Drug: ABBV-722; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events Reported During Safety Evaluations
Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.
Measured: Up to Day 44
Maximum Plasma Concentration (Cmax) of ABBV-722
Cmax of ABBV-722.
Measured: Up to Day 21
Time to Cmax (Tmax) of ABBV-722
Tmax of ABBV-722.
Measured: Up to Day 21
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
AUCt of ABBV-722.
Measured: Up to Day 8
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
AUCinf of ABBV-722
Measured: Up to Day 8
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
Ctrough of ABBV-722.
Measured: Up to Day 21
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
AUC from AUCtau following the first and last doses of ABBV-722.
Measured: Up to Day 21
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
Beta of ABBV-722.
Measured: Up to Day 21
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
t1/2 of ABBV-722.
Measured: Up to Day 21
Dose Normalized Cmax
Dose normalized Cmax.
Measured: Up to Day 21
Dose Normalized AUCs
Dose normalized AUCs.
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start29 Oct 2024
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 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
- NCT06673238
- Sponsor's protocol ID
- M25-150
- Status last verified
- Jul 2026
- First submitted
- 29 Oct 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
- ClinicalTrials.gov ID
- NCT06673238
- Acronym / sponsor ID
- M25-150
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-722
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 4 Nov 2024 (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 is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive a single dose of either ABBV-722 Dose A or placebo. |
| Part 1: Group 2 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive a single dose of either ABBV-722 Dose B or placebo. |
| Part 1: Group 3 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive a single dose of either ABBV-722 Dose C or placebo. |
| Part 1: Group 4 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive a single dose of either ABBV-722 Dose TBD or placebo. |
| Part 1: Group 5 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive a single dose of either ABBV-722 Dose TBD or placebo. |
| Part 2: Group 6 | Experimental | Drug: ABBV-722Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D. |
| Part 2: Group 7 | Experimental | Drug: ABBV-722Participants who are Japanese will receive a single dose of ABBV-722 Dose D. |
| Part 3: Group 8 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive either ABBV-722 Dose E or placebo for 14 days. |
| Part 3: Group 9 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive either ABBV-722 Dose F or placebo for 14 days. |
| Part 3: Group 10 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive either ABBV-722 Dose A or placebo for 14 days. |
| Part 3: Group 11 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive either ABBV-722 Dose G or placebo for 14 days. |
| Part 3: Group 12 | Experimental | Drug: ABBV-722, Drug: PlaceboParticipants will receive either ABBV-722 Dose TBD or placebo for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Laboratory values meet the criteria specified in the protocol.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
- Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.
Key exclusion criteria (3 listed)
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
- Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
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-722Oral Capsule | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 2: Group 6, Part 2: Group 7, Part 3: Group 10, Part 3: Group 11, Part 3: Group 12, Part 3: Group 8, Part 3: Group 9 |
| PlaceboOral Capsule | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 3: Group 10, Part 3: Group 11, Part 3: Group 12, Part 3: Group 8, Part 3: Group 9 |
Primary outcome
Number of Participants with Adverse Events Reported During Safety Evaluations
Time frame: Up to Day 44
Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.
Maximum Plasma Concentration (Cmax) of ABBV-722
Time frame: Up to Day 21
Cmax of ABBV-722.
Time to Cmax (Tmax) of ABBV-722
Time frame: Up to Day 21
Tmax of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
Time frame: Up to Day 8
AUCt of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
Time frame: Up to Day 8
AUCinf of ABBV-722
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
Time frame: Up to Day 21
Ctrough of ABBV-722.
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
Time frame: Up to Day 21
AUC from AUCtau following the first and last doses of ABBV-722.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
Time frame: Up to Day 21
Beta of ABBV-722.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
Time frame: Up to Day 21
t1/2 of ABBV-722.
Dose Normalized Cmax
Time frame: Up to Day 21
Dose normalized Cmax.
Dose Normalized AUCs
Time frame: Up to Day 21
Dose normalized AUCs.
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 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
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-722 in people with Healthy Volunteer, 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 9 inclusion and 3 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 27 Jul 2026. 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 Reported During Safety Evaluations (time frame: Up to Day 44). 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?
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 27 Jul 2026.