Healthy VolunteerPhase 1NCT07141199
A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through the Body of Intravenous Infusions of ABBV-8736 in Adult Healthy Volunteers
A Phase 1 study testing ABBV-8736 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 safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants. 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-8736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 23 Mar 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
- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- 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.
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.
- Prior exposure to a TREM1 agent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-8736 After Multiple Ascending Doses in Healthy Adult Subjects
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-8736, Placebo
- Keywords
- Healthy Volunteer, ABBV-8736
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-8736Drug
Intravenous (IV) Infusion
PlaceboDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dose A of ABBV-8736 | Experimental | Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses. Receives: Drug: ABBV-8736 |
| Group 1: Dose A of ABBV-8736 Placebo | Placebo comparator | Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses. Receives: Drug: Placebo |
| Group 2: Dose B of ABBV-8736 | Experimental | Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses. Receives: Drug: ABBV-8736 |
| Group 2: Dose B of ABBV-8736 Placebo | Placebo comparator | Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses. Receives: 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 Approximately 113 Days
Maximum Observed Concentration (Cmax) of ABBV-8736
Cmax of ABBV-8736.
Measured: Up to Approximately 113 Days
Time to Cmax (Tmax) of ABBV-8736
Tmax of ABBV-8736.
Measured: Up to Approximately 113 Days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736
AUCtau of ABBV-8736.
Measured: Up to Approximately 113 Days
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736
Ctrough of ABBV-8736.
Measured: Up to Approximately 113 Days
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736
β of ABBV-8736.
Measured: Up to Approximately 113 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736
t1/2 of ABBV-8736.
Measured: Up to Approximately 113 Days
Clearance (CL) for Intravenous (IV) Dosing
CL for IV dosing.
Measured: Up to Approximately 113 Days
Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
Measured: Up to Approximately 113 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start2 Sep 2025
- Primary completion23 Mar 2026
- Study completion23 Mar 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 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
- NCT07141199
- Sponsor's protocol ID
- M25-918
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2025
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-8736 After Multiple Ascending Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07141199
- Acronym / sponsor ID
- M25-918
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-8736
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 26 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 assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dose A of ABBV-8736 | Experimental | Drug: ABBV-8736Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses. |
| Group 1: Dose A of ABBV-8736 Placebo | Placebo comparator | Drug: PlaceboParticipants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses. |
| Group 2: Dose B of ABBV-8736 | Experimental | Drug: ABBV-8736Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses. |
| Group 2: Dose B of ABBV-8736 Placebo | Placebo comparator | Drug: PlaceboParticipants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- 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.
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.
- Prior exposure to a TREM1 agent.
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-8736Intravenous (IV) Infusion | Drug | Group 1: Dose A of ABBV-8736, Group 2: Dose B of ABBV-8736 |
| PlaceboIV Infusion | Drug | Group 1: Dose A of ABBV-8736 Placebo, Group 2: Dose B of ABBV-8736 Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately 113 Days
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 Concentration (Cmax) of ABBV-8736
Time frame: Up to Approximately 113 Days
Cmax of ABBV-8736.
Time to Cmax (Tmax) of ABBV-8736
Time frame: Up to Approximately 113 Days
Tmax of ABBV-8736.
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736
Time frame: Up to Approximately 113 Days
AUCtau of ABBV-8736.
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736
Time frame: Up to Approximately 113 Days
Ctrough of ABBV-8736.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736
Time frame: Up to Approximately 113 Days
β of ABBV-8736.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736
Time frame: Up to Approximately 113 Days
t1/2 of ABBV-8736.
Clearance (CL) for Intravenous (IV) Dosing
Time frame: Up to Approximately 113 Days
CL for IV dosing.
Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)
Time frame: Up to Approximately 113 Days
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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
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-8736 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 2 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 28 Apr 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. Some participants in this study may receive a placebo. 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 Approximately 113 Days). 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 28 Apr 2026.