Healthy VolunteersPhase 1NCT07136103
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
A Phase 1 study testing ABBV-277 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 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 Volunteers
- What is being tested?
- ABBV-277
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 11 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
- Body weight ≥ 35 kg
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
- Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
- 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.
- History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-277, Placebo
- Keywords
- Healthy Volunteers, ABBV-277
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-277Drug
- Intravenous (IV) infusion
PlaceboDrug
- Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ABBV-277-Dose A | Experimental | Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days Receives: Drug: ABBV-277 |
| Group 1: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days Receives: Drug: Placebo |
| Group 2: ABBV-277-Dose B | Experimental | Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days Receives: Drug: ABBV-277 |
| Group 2: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days Receives: Drug: Placebo |
| Group 3: ABBV-277-Dose C | Experimental | Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days Receives: Drug: ABBV-277 |
| Group 3: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days Receives: Drug: Placebo |
| Group 4: ABBV-277-Dose D | Experimental | Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days Receives: Drug: ABBV-277 |
| Group 4: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days Receives: Drug: Placebo |
| Group 5: ABBV-277-Dose E | Experimental | Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days Receives: Drug: ABBV-277 |
| Group 5: Placebo | Experimental | Participants will receive Placebo on day 1 and day 2 and followed for 196 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-277
Cmax of ABBV-277
Measured: Up to approximately 9 days
Time to Cmax (Tmax) of ABBV-277
Tmax of ABBV-277
Measured: Up to approximately 9 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-277
Terminal phase elimination rate constant (beta) of ABBV-277
Measured: Up to approximately 9 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-277
Terminal phase elimination half-life of ABBV-277
Measured: Up to approximately 9 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277
AUCt of ABBV-277
Measured: Up to approximately 9 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277
AUCinf of ABBV-277
Measured: Up to approximately 9 days
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant 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 Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start19 Aug 2025
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT07136103
- Sponsor's protocol ID
- M24-934
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2025
- Last updated
- 8 Jul 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07136103
- Acronym / sponsor ID
- M24-934
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, ABBV-277
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 22 Aug 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.
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1: ABBV-277-Dose A | Experimental | Drug: ABBV-277Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days |
| Group 1: Placebo | Experimental | Drug: PlaceboParticipants will receive Placebo on day 1 and followed for 196 days |
| Group 2: ABBV-277-Dose B | Experimental | Drug: ABBV-277Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days |
| Group 2: Placebo | Experimental | Drug: PlaceboParticipants will receive Placebo on day 1 and followed for 196 days |
| Group 3: ABBV-277-Dose C | Experimental | Drug: ABBV-277Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days |
| Group 3: Placebo | Experimental | Drug: PlaceboParticipants will receive Placebo on day 1 and followed for 196 days |
| Group 4: ABBV-277-Dose D | Experimental | Drug: ABBV-277Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days |
| Group 4: Placebo | Experimental | Drug: PlaceboParticipants will receive Placebo on day 1 and followed for 196 days |
| Group 5: ABBV-277-Dose E | Experimental | Drug: ABBV-277Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days |
| Group 5: Placebo | Experimental | Drug: PlaceboParticipants will receive Placebo on day 1 and day 2 and followed for 196 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight ≥ 35 kg
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Key exclusion criteria (5 listed)
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
- Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
- 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.
- History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
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-277• Intravenous (IV) infusion | Drug | Group 1: ABBV-277-Dose A, Group 2: ABBV-277-Dose B, Group 3: ABBV-277-Dose C, Group 4: ABBV-277-Dose D, Group 5: ABBV-277-Dose E |
| Placebo• Intravenous (IV) infusion | Drug | Group 1: Placebo, Group 2: Placebo, Group 3: Placebo, Group 4: Placebo, Group 5: Placebo |
Primary outcome
Maximum Plasma Concentration (Cmax) of ABBV-277
Time frame: Up to approximately 9 days
Cmax of ABBV-277
Time to Cmax (Tmax) of ABBV-277
Time frame: Up to approximately 9 days
Tmax of ABBV-277
Terminal Phase Elimination Rate Constant (Beta) of ABBV-277
Time frame: Up to approximately 9 days
Terminal phase elimination rate constant (beta) of ABBV-277
Terminal Phase Elimination Half-Life (t1/2) of ABBV-277
Time frame: Up to approximately 9 days
Terminal phase elimination half-life of ABBV-277
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277
Time frame: Up to approximately 9 days
AUCt of ABBV-277
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277
Time frame: Up to approximately 9 days
AUCinf of ABBV-277
Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 196
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant 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
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 8 Jul 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-277 in people with Healthy Volunteers, 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 3 inclusion and 5 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 8 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 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?
Maximum Plasma Concentration (Cmax) of ABBV-277 (time frame: Up to approximately 9 days). 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 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.