Healthy VolunteerPhase 1NCT06774313
A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) Infusions of ABBV-142 Move Through the Body of Healthy Adult Participants
A Phase 1 study testing ABBV-142 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-142
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2025to 8 Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Parts:
- Volunteers in general good health.
- Part 3, ONLY:
- HAN CHINESE Participants:
- 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.
- 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.
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- Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent.
- OR
- JAPANESE Participants:
- Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health.
- First-generation participants will have been born in Japan to two parents and four grandparents 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.
- Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-142, Placebo
- Keywords
- Healthy Volunteer, ABBV-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-142Drug
Intravenous (IV) Infusion
ABBV-142Drug
Subcutaneous (SC) Injection
PlaceboDrug
IV Infusion
PlaceboDrug
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive ABBV-142 Dose A or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 1: Group 2 | Experimental | Participants will receive ABBV-142 Dose B or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 1: Group 3 | Experimental | Participants will receive ABBV-142 Dose C or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 1: Group 4 | Experimental | Participants will receive ABBV-142 Dose D or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 1: Group 5 (Optional) | Experimental | Participants will receive ABBV-142 Dose TBD or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 2: Group 6 | Experimental | Participants will receive ABBV-142 Dose B or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 2: Group 7 | Experimental | Participants will receive ABBV-142 Dose C or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 3: Group 8 | Experimental | Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Receives: Drug: ABBV-142; Drug: Placebo |
| Part 3: Group 9 | Experimental | Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. Receives: Drug: ABBV-142; 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 (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.
Measured: Up to Day 120
Maximum Observed Serum Concentration (Cmax) of ABBV-142
Cmax of ABBV-142 will be assessed.
Measured: Up to Day 120
Time to Cmax (Tmax) of ABBV-142
Tmax of ABBV-142 will be assessed.
Measured: Up to Day 120
Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
AUCt of ABBV-142 will be determined.
Measured: Up to Day 120
AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
AUCinf of ABBV-142 will be assessed.
Measured: Up to Day 120
Terminal Phase Elimination Rate Constant (β) of ABBV-142
Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.
Measured: Up to Day 120
Terminal Phase Elimination Half-life (t1/2) of ABBV-142
Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.
Measured: Up to Day 120
Dose Normalized Cmax of ABBV-142
Dose normalized Cmax of ABBV-142 will be assessed.
Measured: Up to Day 120
Dose Normalized AUC of ABBV-142
Dose normalized AUC of ABBV-142 will be assessed.
Measured: Up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start22 Jan 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 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
- NCT06774313
- Sponsor's protocol ID
- M25-265
- Status last verified
- May 2026
- First submitted
- 9 Jan 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects
- ClinicalTrials.gov ID
- NCT06774313
- Acronym / sponsor ID
- M25-265
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-142
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 14 Jan 2025 (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 is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose A or Placebo on Day 1. |
| Part 1: Group 2 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose B or Placebo on Day 1. |
| Part 1: Group 3 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose C or Placebo on Day 1. |
| Part 1: Group 4 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose D or Placebo on Day 1. |
| Part 1: Group 5 (Optional) | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose TBD or Placebo on Day 1. |
| Part 2: Group 6 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose B or Placebo on Day 1. |
| Part 2: Group 7 | Experimental | Drug: ABBV-142, Drug: PlaceboParticipants will receive ABBV-142 Dose C or Placebo on Day 1. |
| Part 3: Group 8 | Experimental | Drug: ABBV-142, Drug: PlaceboHan Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. |
| Part 3: Group 9 | Experimental | Drug: ABBV-142, Drug: PlaceboJapanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Volunteers in general good health.
- 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.
- 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
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.
- Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
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-142Intravenous (IV) Infusion | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5 (Optional), Part 3: Group 8, Part 3: Group 9 |
| ABBV-142Subcutaneous (SC) Injection | Drug | Part 2: Group 6, Part 2: Group 7 |
| PlaceboIV Infusion | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5 (Optional), Part 3: Group 8, Part 3: Group 9 |
| PlaceboSC Injection | Drug | Part 2: Group 6, Part 2: Group 7 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 120
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-142
Time frame: Up to Day 120
Cmax of ABBV-142 will be assessed.
Time to Cmax (Tmax) of ABBV-142
Time frame: Up to Day 120
Tmax of ABBV-142 will be assessed.
Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
Time frame: Up to Day 120
AUCt of ABBV-142 will be determined.
AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
Time frame: Up to Day 120
AUCinf of ABBV-142 will be assessed.
Terminal Phase Elimination Rate Constant (β) of ABBV-142
Time frame: Up to Day 120
Terminal phase elimination rate constant (β) of ABBV-142 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-142
Time frame: Up to Day 120
Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed.
Dose Normalized Cmax of ABBV-142
Time frame: Up to Day 120
Dose normalized Cmax of ABBV-142 will be assessed.
Dose Normalized AUC of ABBV-142
Time frame: Up to Day 120
Dose normalized AUC of ABBV-142 will be assessed.
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 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. This study is not recruiting at the moment.
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-142 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 12 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 6 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?
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 (AEs) (time frame: Up to Day 120). The study lists 9 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 6 May 2026.