Healthy VolunteerPhase 1NCT07570147
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Doses of ABBV-1451 Infusions and Injections in Healthy Adult Participants
A Phase 1 study testing ABBV-1451 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-1451
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
- Applies to Part 2 only:
- For Japanese participants:
- -- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. 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. Participants must be in general good health.
- For Han Chinese participants:
- Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.
Who cannot join
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- 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 treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Acpru /Id# 282128
Grayslake, Illinois, 60030
About this study
Official title: A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-1451, Placebo
- Keywords
- Healthy Volunteer, ABBV-1451
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1451Drug
Injection
ABBV-1451Drug
Infusion
PlaceboOther
Injection
PlaceboOther
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 1: Group 2 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 1: Group 3 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 1: Group 4 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 1: Group 5 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 1: Group 6 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 2: Group 7 | Experimental | Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
| Part 2: Group 8 | Experimental | Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo. Receives: Drug: ABBV-1451; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to Approximately Day 211
Maximum Observed Plasma Concentration (Cmax) of ABBV-1451
Cmax of ABBV-1451.
Measured: Up to Approximately Day 211
Time to Cmax (Tmax) of ABBV-1451
Tmax of ABBV-1451.
Measured: Up to Approximately Day 211
Terminal Phase Elimination Rate Constant (β) of ABBV-1451
β of ABBV-1451.
Measured: Up to Approximately Day 211
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451
t1/2 of ABBV-1451.
Measured: Up to Approximately Day 211
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451
AUCt of ABBV-1451.
Measured: Up to Approximately Day 211
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451
AUCinf of ABBV-1451.
Measured: Up to Approximately Day 211
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
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
- NCT07570147
- Sponsor's protocol ID
- M26-116
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT07570147
- Acronym / sponsor ID
- M26-116
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-1451
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 May 2026 (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.
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. |
| Part 1: Group 2 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo. |
| Part 1: Group 3 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. |
| Part 1: Group 4 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. |
| Part 1: Group 5 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. |
| Part 1: Group 6 | Experimental | Drug: ABBV-1451, Other: PlaceboParticipants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo. |
| Part 2: Group 7 | Experimental | Drug: ABBV-1451, Other: PlaceboJapanese participants will receive a single dose of ABBV-1451 Dose C or placebo. |
| Part 2: Group 8 | Experimental | Drug: ABBV-1451, Other: PlaceboHan Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
- Applies to Part 2 only:
- For Japanese participants:
- -- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. 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. Participants must be in general good health.
- For Han Chinese participants:
Key exclusion criteria (3 listed)
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- 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 treatment.
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-1451Injection | Drug | Part 1: Group 1, Part 1: Group 2, Part 2: Group 8 |
| ABBV-1451Infusion | Drug | Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 1: Group 6, Part 2: Group 7 |
| PlaceboInjection | Other | Part 1: Group 1, Part 1: Group 2, Part 2: Group 8 |
| PlaceboInfusion | Other | Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 1: Group 6, Part 2: Group 7 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Day 211
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of ABBV-1451
Time frame: Up to Approximately Day 211
Cmax of ABBV-1451.
Time to Cmax (Tmax) of ABBV-1451
Time frame: Up to Approximately Day 211
Tmax of ABBV-1451.
Terminal Phase Elimination Rate Constant (β) of ABBV-1451
Time frame: Up to Approximately Day 211
β of ABBV-1451.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451
Time frame: Up to Approximately Day 211
t1/2 of ABBV-1451.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451
Time frame: Up to Approximately Day 211
AUCt of ABBV-1451.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451
Time frame: Up to Approximately Day 211
AUCinf of ABBV-1451.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
1 site 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-1451 in people with Healthy Volunteer, run by AbbVie at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to Approximately Day 211). The study lists 7 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 28 May 2026.