Healthy VolunteerPhase 1NCT07413133
A Study to Assess How the Body Absorbs ABBV-8736 Subcutaneous Injections Relative to Intravenous Injections in Adult Healthy Volunteers
A Phase 1 study testing ABBV-8736 in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration. 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-8736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2026to 19 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight >= 35 kg.
- 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).
Who cannot join
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis.
- Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration.
- Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration.
- Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) agent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel ACT- Anaheim Clinical Trials /ID# 280481
Anaheim, California, 92801
Acpru /Id# 280382
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Pharmacokinetic Study in Healthy Adult Volunteers to Evaluate the Bioavailability of ABBV-8736 Following Subcutaneous Administration Relative to Intravenous Administration
The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-8736
- 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 Injection
ABBV-8736Drug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intravenous (IV) ABBV-8736 | Experimental | Participants will receive IV ABBV-8736 on Day 1. Receives: Drug: ABBV-8736 |
| Arm 2: Subcutaneous (SC) ABBV-8736 | Experimental | Participants will receive SC ABBV-8736 on Day 1. Receives: Drug: ABBV-8736 |
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 At Least 3 Months
Maximum Observed Serum Concentration (Cmax) of ABBV-8736
Cmax of ABBV-8736.
Measured: Up to At Least 3 Months
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736
Tmax of ABBV-8736.
Measured: Up to At Least 3 Months
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736
AUClast of ABBV-8736.
Measured: Up to At Least 3 Months
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736
AUCinf of ABBV-8736.
Measured: Up to At Least 3 Months
Terminal Phase Elimination Rate Constant (β) of ABBV-8736
β of ABBV-8736.
Measured: Up to At Least 3 Months
Terminal Elimination Half-Life (t1/2) of ABBV-8736
t1/2 of ABBV-8736.
Measured: Up to At Least 3 Months
Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736
CL of ABBV-8736.
Measured: Up to At Least 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Feb 2026
- Primary completion19 Jun 2026
- Study completion19 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT07413133
- Sponsor's protocol ID
- M25-478
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Study in Healthy Adult Volunteers to Evaluate the Bioavailability of ABBV-8736 Following Subcutaneous Administration Relative to Intravenous Administration
- ClinicalTrials.gov ID
- NCT07413133
- Acronym / sponsor ID
- M25-478
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-8736
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 17 Feb 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 purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intravenous (IV) ABBV-8736 | Experimental | Drug: ABBV-8736Participants will receive IV ABBV-8736 on Day 1. |
| Arm 2: Subcutaneous (SC) ABBV-8736 | Experimental | Drug: ABBV-8736Participants will receive SC ABBV-8736 on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight >= 35 kg.
- 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).
Key exclusion criteria (4 listed)
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis.
- Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration.
- Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration.
- Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (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 Injection | Drug | Arm 1: Intravenous (IV) ABBV-8736 |
| ABBV-8736Subcutaneous Injection | Drug | Arm 2: Subcutaneous (SC) ABBV-8736 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to At Least 3 Months
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-8736
Time frame: Up to At Least 3 Months
Cmax of ABBV-8736.
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736
Time frame: Up to At Least 3 Months
Tmax of ABBV-8736.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736
Time frame: Up to At Least 3 Months
AUClast of ABBV-8736.
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736
Time frame: Up to At Least 3 Months
AUCinf of ABBV-8736.
Terminal Phase Elimination Rate Constant (β) of ABBV-8736
Time frame: Up to At Least 3 Months
β of ABBV-8736.
Terminal Elimination Half-Life (t1/2) of ABBV-8736
Time frame: Up to At Least 3 Months
t1/2 of ABBV-8736.
Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736
Time frame: Up to At Least 3 Months
CL of ABBV-8736.
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 20 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
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-8736 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 3 inclusion and 4 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 20 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 (AEs) (time frame: Up to At Least 3 Months). The study lists 8 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 20 Jul 2026.